Hospital Acquired PneumoniaREACTNCT05487586
Real-World Study of Ceftazidime Avibactam in China
An observational study of Hospital Acquired Pneumonia and Ventilator Acquired Pneumonia, run by Pfizer at 17 sites in China.
Trial summary
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- What is being tested?
- ceftazidime avibactam group
- How many people
- 220 participants
- Where
- 17 sitesChina
- Study dates
- 20 Oct 2022to 11 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.
Who may be able to join
- Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
- Aged ≥ 18 years old at the time of the informed consent signature.
- Provide signed informed consent. Exclusion criteria：
- Are enrolled in any clinical trial, including enrollment in non interventional studies.
- Pregnant women.
Who cannot join
None listed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Beijing Tsinghua Changgung Hospital
Beijing
Xiangya Hospital Central South University
Changsha
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
The First affiliated Hospital of Anhui Medical University
Hefei
The First Affiliated Hospital of Nanchang University
Nanchang
Zhongda Hospital Southeast University
Nanjing
The Affiliated People's Hospital of Ningbo University
Ningbo
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Tenth People's Hospital
Shanghai
The Second People's Hospital of Hebei Medical University
Shijiazhuang
The Third Hospital of Hebei Medical University
Shijiazhuang
The First Affiliated Hospital of Soochow University
Suzhou
Tianjin Medical University General Hospital
Tianjing
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Henan Provincial People's Hospital
Zhengzhou
About this study
Official title: Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
Read the detailed description
The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.
- Conditions
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- Being tested
- ceftazidime avibactam group
- Keywords
- hospital acquired pneumonia, ventilator acquired pneumonia, complicated intra abdominal infections, ceftazidime avibactam, carbapenem-resistant Enterobacteriaceae
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftazidime avibactam groupDrug
Also called CAZ/AVI group
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| ceftazidime avibactam group | Receive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature. Receives: Drug: ceftazidime avibactam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Rate at Day 7
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: Day 7 (from the data evaluated in approximately 21 months of the study)
Clinical Success Rate at Day 14
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: Day 14 (from the data evaluated in approximately 21 months of the study)
Clinical Success Rate at Day 21
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: Day 21 (from the data evaluated in approximately 21 months of the study)
Clinical Success Rate at Day 30
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: Day 30 (from the data evaluated in approximately 21 months of the study)
Clinical Success Rate at Day 60
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: Day 60 (from the data evaluated in approximately 21 months of the study)
Clinical Success Rate at End of Treatment (EOT)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Measured: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 7 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 14 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 21 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 30 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 60 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 7 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 14 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 21 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 30 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 60 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 7 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 14 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 21 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 30 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 60 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 7 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 14 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 21 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 30 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: Day 60 (from the data evaluated in approximately 21 months of the study)
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Measured: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Measured: At index date (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Source of Infection
Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Measured: At index date (from the data evaluated in approximately 21 months of the study)
Number of Isolated Strains
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic.
Measured: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Number of Carbapenem-Resistant Strains
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
Secondary outcomes (22)
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once.
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Frequency of Ceftazidime-Avibactam was divided into: BID = Bis in die (twice a day), TID = Ter in die (thrice a day) and QD = Quaque die (once a day). A participant who had more than one record of treatment within the same dosage and frequency was counted only once.
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set
For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods.
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
For a participant, each ceftazidime-avibactam administration period (days) was calculated as: ceftazidime-avibactam administration end date - ceftazidime-avibactam administration start date + 1. Duration of exposure (days) was obtained by summing up all ceftazidime-avibactam administration periods.
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Measured: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Hospital Length of Stay (LOS): Full Analysis Set
Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Hospital Length of Stay (LOS): CE Analysis Set
Hospital LOS was defined as date of hospital discharge minus date of hospital admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Intensive Care Unit (ICU) LOS: Full Analysis Set
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
ICU LOS: Clinically Evaluable Analysis Set
Duration of ICU stay was defined as date of ICU discharge minus date of ICU admission plus 1. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Measured: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
The number of participants reported according to the most frequent diagnosis at admission to the hospital were reported in this outcome measure.
Measured: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Measured: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
The number of participants reported according to the most frequent diagnosis at discharge from the hospital were reported in this outcome measure.
Measured: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set
The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set
The number of participants with at least 1 concomitant procedure were reported in this outcome measure. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Duration of Mechanical Ventilation: Full Analysis Set
For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set
For a participant, each mechanical ventilation period (days) was calculated as: mechanical ventilation end date - mechanical ventilation start date + 1. Length of mechanical ventilation (days) was obtained by summing up all mechanical ventilation periods. The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Measured: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set
95% CI was based on Clopper-Pearson method.
Measured: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set
95% CI was based on Clopper-Pearson method.
Measured: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Percentage of Participants Who Died During Hospitalization: Full Analysis Set
In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method.
Measured: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set
In hospital-mortality was defined as deaths occurring after treatment initiation but before hospital discharge. The percentage of participants who died during index hospitalization were reported in this outcome measure. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria. 95% CI was based on Clopper-Pearson method.
Measured: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start20 Oct 2022
- Primary completion11 Jul 2024
- Study completion11 Jul 2024
Why it stopped: The study was prematurely discontinued due to slow enrollment and strategic considerations. This decision was not based on any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hospital Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487586
- Sponsor's protocol ID
- C3591037
- Acronym
- REACT
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2022
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of Ceftazidime-Avibactam to Characterize the Usage in Clinical Practice
- ClinicalTrials.gov ID
- NCT05487586
- Acronym / sponsor ID
- REACT / C3591037
- Conditions
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- Keywords
- hospital acquired pneumonia, ventilator acquired pneumonia, complicated intra abdominal infections, ceftazidime avibactam, carbapenem-resistant Enterobacteriaceae
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to slow enrollment and strategic considerations. This decision was not based on any safety or efficacy concerns.
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
Detailed description
The recruitment will last for approximately 6 months or until recruitment target is met, and information about treatment will be collected from the patients' medical records. Patients will be followed from CAZ AVI initiation until death, withdraw of the study, 60 days after discharged from the hospitalization, whichever comes first. The endpoint events will be evaluated at: 7 days, 14 days, 21 days, 30 days, 60 days, and end of treatment (EOT) after CAZ AVI initiation, if patients are not discharged prior to the next upcoming timepoint; and 30 days, 60 days after discharge.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ceftazidime avibactam group | – | Drug: ceftazidime avibactam groupReceive ≥1 dose of ceftazidime avibactam in routine practice; Aged ≥ 18 years old at the time of the informed consent signature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients treated with CAZ AVI for ≥1 dose in approximately 20 study sites.
Key inclusion criteria (5 listed)
- Initiate ≥1 dose of ceftazidime-avibactam during hospitalization.
- Aged ≥ 18 years old at the time of the informed consent signature.
- Provide signed informed consent. Exclusion criteria：
- Are enrolled in any clinical trial, including enrollment in non interventional studies.
- Pregnant women.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceftazidime avibactam groupAlso: CAZ/AVI groupNon-Interventional Study | Drug | ceftazidime avibactam group |
Primary outcome
Clinical Success Rate at Day 7
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Clinical Success Rate at Day 14
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Clinical Success Rate at Day 21
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Clinical Success Rate at Day 30
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Clinical Success Rate at Day 60
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Clinical Success Rate at End of Treatment (EOT)
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
The clinical success rate was defined as the number of participants with clinical outcome as "success" in a specific visit / number of participants with clinical outcome assessed in a specific visit and was reported in terms of percentage of participants. Clinical outcome as success was defined as resolution of all signs and symptoms of infection such that no further antimicrobial therapy was necessary. 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 7
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (gram positive/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 14
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 21
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 30
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at Day 60
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Site Investigator at EOT
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 7
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 14
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 21
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 30
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at Day 60
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate Based on the Evaluation by Central Laboratory at EOT
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 7
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 14
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 21
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 30
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at Day 60
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Site Investigator at EOT
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 7
Time frame: Day 7 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 14
Time frame: Day 14 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 21
Time frame: Day 21 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 30
Time frame: Day 30 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at Day 60
Time frame: Day 60 (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Microbiological Success Rate by Pathogen Based on the Evaluation by Central Laboratory at EOT
Time frame: At EOT (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
The microbiological success rate was defined as the number of participants with microbiological outcome "success" in a specific visit / number of participants with microbiological outcome assessed in a specific visit and was reported in terms of percentage of participants. Microbiological outcome as success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication), repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication) and detection of pathogen from the site of infection during therapy without need for antimicrobial treatment or a superinfection with a microbiological agent outside the treatment spectrum of ceftazidime-avibactam (G+/fungi) (colonization). 95% CI was based on Clopper-Pearson method.
Number of Participants According to Indication for Ceftazidime-Avibactam at Index Date
Time frame: At index date (from the data evaluated in approximately 21 months of the study)
Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Number of Participants According to Source of Infection
Time frame: At index date (from the data evaluated in approximately 21 months of the study)
Index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligibility criteria.
Number of Isolated Strains
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
Number of Strains With Resistance to Ceftazidime-Avibactam and Other Antibiotic Drugs
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participant's first hospitalization met the eligible criteria. Number of strains with resistance to ceftazidime-avibactam and other antibiotic drugs is reported. One strain could be resistant to more than one antibiotic.
Number of Carbapenem-Resistant Strains
Time frame: At baseline (from 7 days prior to index date until index date) (from the data evaluated in approximately 21 months of the study)
The index date was defined as the date when participants initiated >=1 dose of ceftazidime-avibactam treatment during the index hospitalization. Index hospitalization was defined as when participants' first hospitalization met the eligible criteria.
22 secondary outcomes
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Full Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Dose and Frequency of Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Duration of Exposure to Ceftazidime-Avibactam: Full Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Duration of Exposure to Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Full Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Number of Participants Who Received Combination Therapy With Ceftazidime-Avibactam: Clinically Evaluable Analysis Set
Time frame: From start of index treatment to end of index treatment (maximum 86 days of treatment exposure) (from the data evaluated in approximately 21 months of the study)
Hospital Length of Stay (LOS): Full Analysis Set
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Hospital Length of Stay (LOS): CE Analysis Set
Time frame: From index date up to hospital discharge, in-hospital death, withdrawal from study, or lost to follow-up, whichever occurred first (approximately 27 months including 6 months of index period); (from data evaluated in approximately 21 months of the study)
Intensive Care Unit (ICU) LOS: Full Analysis Set
Time frame: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
ICU LOS: Clinically Evaluable Analysis Set
Time frame: During index hospitalization, approximately 27 months including 6 months of index period; (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Admission: Full Analysis Set
Time frame: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Admission: Clinically Evaluable Analysis Set
Time frame: At admission to the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Discharge: Full Analysis Set
Time frame: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants According to Most Frequent Diagnosis at Discharge: Clinically Evaluable Analysis Set
Time frame: At discharge from the hospital (from the data evaluated in approximately 21 months of the study)
Number of Participants With at Least 1 Concomitant Procedures: Full Analysis Set
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Number of Participants With at Least 1 Concomitant Procedures: Clinically Evaluable Analysis Set
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Duration of Mechanical Ventilation: Full Analysis Set
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Duration of Mechanical Ventilation: Clinically Evaluable Analysis Set
Time frame: From start of index treatment until death, withdraw of the study, 60 days following hospital discharge, whichever comes first (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: Full Analysis Set
Time frame: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Percentage of Participants With Readmission Due to Recurrence of Infection Within 30 Days and 31-60 Days After Discharge: CE Analysis Set
Time frame: Within 30 days and 31-60 days after discharge (from the data evaluated in approximately 21 months of the study)
Percentage of Participants Who Died During Hospitalization: Full Analysis Set
Time frame: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Percentage of Participants Who Died During Hospitalization: Clinically Evaluable Analysis Set
Time frame: During index hospitalization (approximately 27 months including 6 months of index period); (from the data evaluated in approximately 21 months of the study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Acquired Pneumonia and Ventilator Acquired Pneumonia, run by Pfizer at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate at Day 7 (time frame: Day 7 (from the data evaluated in approximately 21 months of the study)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.