Ventilator Associated PneumoniaNCT04352855
Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.
An observational study of Ventilator Associated Pneumonia and Antibiotic Resistant Infection, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Ventilator Associated Pneumonia, Antibiotic Resistant Infection
- What is being tested?
- Ceftolozane/tazobactam
- How many people
- 55 participants
- Where
- 1 siteHungary
- Study dates
- 18 Jan 2018to 19 May 2020
- 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 16 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Patients admitted to a multideisciplanry academic terciary care ICU, suffering from ventilation associated pneumonia, caused by XDR or panresistant Pseudomonas Aeruginosa
Who may be able to join
- Hospital-acquired pneumonia caused by extensively drug-resistant Pseudomonas aeruginosa
- ≥ 72 hours of targeted antibiotic therapy against Pseudomonas aeruginosa with either Colomycin or Ceftolozane-Tazobactam
Who cannot join
- Participation in an interventional trial aiming nosocomial infections
- Treatment was not with the intent to cure the infection
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.
Read the detailed description
Ceftolozane-tazobactam (C/T) is a novel type of beta-lactam/beta-lactamase inhibitor antibiotics targeting nosocomial infections caused by Gram-negative bacteria. In recent years, ceftolozane-tazobactam was prescribed for treating complicated urinary tract infections (cUTI) and complicated intraabdominal infections (cIAI). Following the results of ASPECT-NP trial in 2019, it was approved as a therapeutic option in nosocomial pneumonia including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
The drug shows an excellent activity against ESBL-producing Enterobacterales and multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains of Pseudomonas aeruginosa. The latter is widely recognized as a common pathogen of nosocomial respiratory tract infections.
There is still a need for observations of clinical experiences to better define the risk-benefit profile of ceftolozane-tazobactam. The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.
- Being tested
- Ceftolozane/tazobactam
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftolozane/tazobactamDrug
Administration
| Study group | Role | What they receive |
|---|---|---|
| C/T | C/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam Receives: Drug: Ceftolozane/tazobactam | |
| C | C cases: individuals fulfilling eligibility criteria and treated with colomycine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Measured: 7-14 day
Microbiological cure rate
Measured: 7-14 day
Secondary outcomes (4)
LOS
Lenght of ICU stay
Measured: 28
Length of ventilation
Measured: Untill patient is ventilated (expected time frame is 10 days)
28 day mortality
Measured: 28
Drug related adverse events rate
The number and nature
Measured: until ICU discharge (expected average day is 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start18 Jan 2018
- Primary completion19 May 2020 (estimated)
- Study completion19 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Semmelweis 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zsolt Iványi, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352855
- Sponsor's protocol ID
- SE58/2020
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT04352855
- Acronym / sponsor ID
- SE58/2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 19 May 2020 (estimated)
- Study completion
- 19 May 2020 (estimated)
- First posted
- 20 Apr 2020 (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.
The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.
Detailed description
Ceftolozane-tazobactam (C/T) is a novel type of beta-lactam/beta-lactamase inhibitor antibiotics targeting nosocomial infections caused by Gram-negative bacteria. In recent years, ceftolozane-tazobactam was prescribed for treating complicated urinary tract infections (cUTI) and complicated intraabdominal infections (cIAI). Following the results of ASPECT-NP trial in 2019, it was approved as a therapeutic option in nosocomial pneumonia including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
The drug shows an excellent activity against ESBL-producing Enterobacterales and multidrug-resistant (MDR) and extensively drug-resistant (XDR) strains of Pseudomonas aeruginosa. The latter is widely recognized as a common pathogen of nosocomial respiratory tract infections.
There is still a need for observations of clinical experiences to better define the risk-benefit profile of ceftolozane-tazobactam. The aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of ICU dependent nosocomial respiratory tract infections due to extensively drug resistant Pseudomonas aeruginosa. Different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of Colomycin.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C/T | – | Drug: Ceftolozane/tazobactamC/T cases: individuals fulfilling eligibility criteria and treated with ceftolozane-tazobactam |
| C | – | –C cases: individuals fulfilling eligibility criteria and treated with colomycine |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to a multideisciplanry academic terciary care ICU, suffering from ventilation associated pneumonia, caused by XDR or panresistant Pseudomonas Aeruginosa
Key inclusion criteria (2 listed)
- Hospital-acquired pneumonia caused by extensively drug-resistant Pseudomonas aeruginosa
- ≥ 72 hours of targeted antibiotic therapy against Pseudomonas aeruginosa with either Colomycin or Ceftolozane-Tazobactam
Key exclusion criteria (2 listed)
- Participation in an interventional trial aiming nosocomial infections
- Treatment was not with the intent to cure the infection
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 |
|---|---|---|
| Ceftolozane/tazobactamAdministration | Drug | C/T |
Primary outcome
Clinical cure rate
Time frame: 7-14 day
Microbiological cure rate
Time frame: 7-14 day
4 secondary outcomes
LOS
Time frame: 28
Length of ventilation
Time frame: Untill patient is ventilated (expected time frame is 10 days)
28 day mortality
Time frame: 28
Drug related adverse events rate
Time frame: until ICU discharge (expected average day is 14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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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.
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 Ventilator Associated Pneumonia and Antibiotic Resistant Infection, run by Semmelweis University at 1 site in Hungary.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2020. 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 Hungary. 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?
Results are not available in the source record.
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 cure rate (time frame: 7-14 day). The study lists 2 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 20 Apr 2020.