MDRPANCT06992102
Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam
An observational study of MDRPA, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Multidrug-resistant Gram-negative bacteria (MDR-GNB) is emerging globally as a pathogen of concern in healthcare-associated infections (HAIs), and a threat to public health.There has been an alarming rise in the prevalence of MDR-GNB infections globally over the last decade.Multidrug-resistant or Carbapenem-resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDRPA
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: This was a single-centre, retrospective and observational study conducted in the First Affiliated Hospital of Nanjing Medical University, a 2200-bed tertiary care teaching hospital in Nanjing, Jiangsu in China, from January 2019 to April 2023.The inclusion criteria consisted of (i) patients with MDRPA infection diagnosed by clinicians,(ii) patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h,(iii) patients older than 18 years old. Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.
Who may be able to join
- patients with MDRPA infection diagnosed by clinicians
- patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h
- patients older than 18 years old.
Who cannot join
- Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 21000
About this study
Multidrug-resistant Gram-negative bacteria (MDR-GNB) is emerging globally as a pathogen of concern in healthcare-associated infections (HAIs), and a threat to public health.There has been an alarming rise in the prevalence of MDR-GNB infections globally over the last decade.Multidrug-resistant or Carbapenem-resistant Pseudomonas aeruginosa (MDRPA or CRPA) are one of the major pathogens in the hospital setting,and are particularly challenging due to limited therapeutic options,associated with high mortality rates.Ceftazidime/avibactam(CAZ/AVI) combines the anti-pseudomonal cephalosporin ceftazidime and the novel non-β-lactam β-lactamase inhibitor avibactam,which are now available for the treatment of MDR-GNB infections and favorable outcomes have been reported in hospitalized patients with carbapenem-resistant Enterobacterales (CRE).However, there are only few publications available with a small sample size limit, focusing on the efficacy of CAZ/AVI for the treatment of CRPA or MDRPA infections.Therefore, a retrospective analysis was conducted to compare the clinical efficacy and microbiological efficacy of CAZ/AVI versus other antibiotics for the treatment of MDRPA infections.
- Conditions
- MDRPA
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
The clinical efficacy of the treatment was determined by two senior physicians with extensive clinical experience, who classified it as either effective (characterized by the resolution or significant improvement of clinical symptoms and signs, normalization or minimal residuals in pulmonary imaging, and normalization of inflammatory markers), uncertain or ineffective.
Measured: 28 day after enrollment
Secondary outcomes (1)
Microbiological efficacy
Microbiological efficacy was defined as eradication or reduction, indicated by the absence of MDRPA in lower respiratory tract secretion cultures post-treatment, or a decrease in bacterial load by more than 25% compared to pre-treatment levels. Microbiological ineffectiveness was defined as the continued presence of MDRAB in cultures after treatment and no change or an increase in bacterial load compared to pre-treatment levels.
Measured: 28 day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDRPAStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992102
- Sponsor's protocol ID
- 2022-SR-500
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Lower Respiratory Tract Infection With Pseudomonas Aeruginosa by Ceftazidime and Avibatam
- ClinicalTrials.gov ID
- NCT06992102
- Acronym / sponsor ID
- 2022-SR-500
- Conditions
- MDRPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multidrug-resistant Gram-negative bacteria (MDR-GNB) is emerging globally as a pathogen of concern in healthcare-associated infections (HAIs), and a threat to public health.There has been an alarming rise in the prevalence of MDR-GNB infections globally over the last decade.Multidrug-resistant or Carbapenem-resistant Pseudomonas aeruginosa (MDRPA or CRPA) are one of the major pathogens in the hospital setting,and are particularly challenging due to limited therapeutic options,associated with high mortality rates.Ceftazidime/avibactam(CAZ/AVI) combines the anti-pseudomonal cephalosporin ceftazidime and the novel non-β-lactam β-lactamase inhibitor avibactam,which are now available for the treatment of MDR-GNB infections and favorable outcomes have been reported in hospitalized patients with carbapenem-resistant Enterobacterales (CRE).However, there are only few publications available with a small sample size limit, focusing on the efficacy of CAZ/AVI for the treatment of CRPA or MDRPA infections.Therefore, a retrospective analysis was conducted to compare the clinical efficacy and microbiological efficacy of CAZ/AVI versus other antibiotics for the treatment of MDRPA infections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This was a single-centre, retrospective and observational study conducted in the First Affiliated Hospital of Nanjing Medical University, a 2200-bed tertiary care teaching hospital in Nanjing, Jiangsu in China, from January 2019 to April 2023.The inclusion criteria consisted of (i) patients with MDRPA infection diagnosed by clinicians,(ii) patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h,(iii) patients older than 18 years old. Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.
Key inclusion criteria (3 listed)
- patients with MDRPA infection diagnosed by clinicians
- patients treated with anti-Pseudomonas aeruginosa antibiotics for at least 72h
- patients older than 18 years old.
Key exclusion criteria (1 listed)
- Patients with human immunodeficiency virus infection, mental illness, a medication course of less than 72 hours, or incomplete data were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical efficacy
Time frame: 28 day after enrollment
The clinical efficacy of the treatment was determined by two senior physicians with extensive clinical experience, who classified it as either effective (characterized by the resolution or significant improvement of clinical symptoms and signs, normalization or minimal residuals in pulmonary imaging, and normalization of inflammatory markers), uncertain or ineffective.
1 secondary outcome
Microbiological efficacy
Time frame: 28 day after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MDRPA, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 efficacy (time frame: 28 day after enrollment). 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 28 May 2025.