- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05535751
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections (CARBAPENEM)
December 12, 2023 updated by: University Hospital, Strasbourg, France
Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies.
As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
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
-
-
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Strasbourg, France, 67091
- Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
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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
Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia
Description
Inclusion criteria:
- Adult patient (≥18 years of age)
- managed within a study center for high-grade cephalosporinase-producing bacteremia
- Not objecting to the reuse of their health data for scientific research purposes.
Exclusion Criteria:
- Patient who has expressed opposition to the reuse of their data for scientific research purposes.
- Resistance to Cefepime or carbapenems
- Multiple bacteremia
- Treatment with a molecule other than Cefepime or carbapenem.
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 |
Time Frame |
---|---|
Hospital mortality
Time Frame: 30 days after infection
|
30 days after infection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
July 20, 2022
Primary Completion (Actual)
May 20, 2023
Study Completion (Actual)
June 20, 2023
Study Registration Dates
First Submitted
September 6, 2022
First Submitted That Met QC Criteria
September 6, 2022
First Posted (Actual)
September 10, 2022
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8660
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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