- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963297
Multicenter Evaluation of the Susceptibility of Enterobacteriaceae and Pseudomonas Aeruginosa to Ceftolozane/Tazobactam Combination (GMC-9)
April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph
Ceftolozane/tazobactam is a new antibiotic with broad spectrum activity.
This molecule is currently one of the most active beta lactams against Pseudomonas aeruginosa and its spectrum of activity also includes enterobacteriaceae producing a broad spectrum beta-lactamase (EBLSE).
Ceftolozane/tazobactam is currently marketed for the treatment of complicated intra-abdominal infections and complicated urinary tract infections.
These intra-abdominal and urinary infections are mainly caused by enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae) and more rarely by P. aeruginosa.
Concerning enterobacteriaceae, French epidemiology reports a prevalence of BLSE of between 10 and 15% in E. coli and 10%-30% in K. pneumoniae.
Study Overview
Status
Completed
Conditions
Detailed Description
Currently, the probabilistic treatment of these multi-resistant bacteria involves the use of carbapenems.
Unfortunately, the increasing and unreasonable use of carbapenems invariably leads to the spread of even more resistant strains, BHRe (Emerging Highly Resistant Bacteria) including enterobacteriaceae producing carbapenemases.
Thus, it is strongly recommended by health authorities to limit the use of carbapenems ("carbapenem savings") by promoting the use of therapeutic alternatives.
Ceftolozane/tazobactam is one of those therapeutic alternatives for which an evaluation must be carried out.
Currently, in addition to complicated intra-abdominal infections and complicated urinary tract infections, ceftolozane/tazobactam combination is used in clinical practice in gram-negative infections such as upper and lower respiratory infections and bacteremia.
In any case, the choice of probabilistic antibiotic therapy must take into account local and regional epidemiological data.
However, published data on the in vitro activity of ceftolozane/tazobactam remain limited, particularly in France (only one French epidemiological study on Gram-negative non-fermenting bacillus strains isolated in patients with cystic fibrosis).
This study does not take into account in particular multi-resistant enterobacteriaceae producing BLSE for which ceftolozane/tazobactam remains effective (particularly in E. coli and K. pneumoniae).
Study Type
Observational
Enrollment (Actual)
747
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Hospitalized patient with community-acquired or nosocomial Gram-negative bacillus infection of enterobacteriaceae or P. aeruginosa type (bacteremia, low respiratory infection, intra-abdominal infection)
Description
Inclusion Criteria:
- Patient whose age is ≥ 18 years old
- Hospitalized patient with community-acquired or nosocomial Gram-negative bacillus infection of enterobacteriaceae or P. aeruginosa type (bacteremia, low respiratory infection, intra-abdominal infection)
- French-speaking patient
Exclusion Criteria:
- Patient under tutorship or curatorship
- Patient deprived of liberty
- Patient under the protection of justice
- Refusal to participate in the study
- Patients judged by the investigator as being unable to express their non-opposition to the study
- Urinary localization of the infection to avoid strains responsible for simple colonization. Indeed, the collection of microbiological data (as carried out in this study) makes it difficult to distinguish between real infection and simple colonization. In addition, the impact of early implementation of appropriate therapy on the evolution of infectious disease (mortality, morbidity, etc.) has been clearly demonstrated for serious infections such as bacteremia and respiratory infections, while this impact remains more limited or even insignificant for urinary infections. Hence the desire to exclude isolated strains of urine samples.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Value of the minimum inhibitory concentration (MIC)
Time Frame: 1 year
|
Value of the minimum inhibitory concentration (MIC) obtained for ceftolozane/tazobactam for each strain
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient History
Time Frame: 1 year
|
Clinical profil of patients (yes/no) correlated with resistance or susceptibility of strains to ceftolozane/tazobactam
|
1 year
|
Number of strains producing ESBL and/or carbapenemase (yes or no)
Time Frame: 1 year
|
biochemical tests (ESBL NDP test and/or Carba NP test)
|
1 year
|
Molecular profil of enterobacteriaceae (produced genes : yes or no)
Time Frame: 1 year
|
Molecular test (PCR + sequencing: blaCTX-M, blaTEM, blaSHV)
|
1 year
|
Molecular profil of pseudomonas aeruginosa (produced genes : yes or no)
Time Frame: 1 year
|
Molecular test (PCR + sequencing : blaGES, blaVEB and blaPER)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alban Le Monnier, Professor, Groupe hospitalier Paris saint Joseph
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Castanheira M, Duncan LR, Mendes RE, Sader HS, Shortridge D. Activity of Ceftolozane-Tazobactam against Pseudomonas aeruginosa and Enterobacteriaceae Isolates Collected from Respiratory Tract Specimens of Hospitalized Patients in the United States during 2013 to 2015. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02125-17. doi: 10.1128/AAC.02125-17. Print 2018 Mar.
- Walkty A, Adam H, Baxter M, Lagace-Wiens P, Karlowsky JA, Hoban DJ, Zhanel GG. In vitro activity of ceftolozane/tazobactam versus antimicrobial non-susceptible Pseudomonas aeruginosa clinical isolates including MDR and XDR isolates obtained from across Canada as part of the CANWARD study, 2008-16. J Antimicrob Chemother. 2018 Mar 1;73(3):703-708. doi: 10.1093/jac/dkx468.
- Monogue ML, Nicolau DP. Antibacterial activity of ceftolozane/tazobactam alone and in combination with other antimicrobial agents against MDR Pseudomonas aeruginosa. J Antimicrob Chemother. 2018 Apr 1;73(4):942-952. doi: 10.1093/jac/dkx483.
- Munita JM, Aitken SL, Miller WR, Perez F, Rosa R, Shimose LA, Lichtenberger PN, Abbo LM, Jain R, Nigo M, Wanger A, Araos R, Tran TT, Adachi J, Rakita R, Shelburne S, Bonomo RA, Arias CA. Multicenter Evaluation of Ceftolozane/Tazobactam for Serious Infections Caused by Carbapenem-Resistant Pseudomonas aeruginosa. Clin Infect Dis. 2017 Jul 1;65(1):158-161. doi: 10.1093/cid/cix014.
- Chen M, Zhang M, Huang P, Lin Q, Sun C, Zeng H, Deng Y. Novel beta-lactam/beta-lactamase inhibitors versus alternative antibiotics for the treatment of complicated intra-abdominal infection and complicated urinary tract infection: a meta-analysis of randomized controlled trials. Expert Rev Anti Infect Ther. 2018 Feb;16(2):111-120. doi: 10.1080/14787210.2018.1429912. Epub 2018 Jan 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GMC-9
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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