- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06185153
Carbapenem Antibiotic Therapy for VIM Carbapenemase-Producing Enterobacteriaceae Infections (CarbaVim)
December 14, 2023 updated by: University Hospital, Strasbourg, France
Carbapenem Antibiotic Therapy for VIM Carbapenemase-Producing Enterobacteriaceae Infections - A Retrospective Cohort Study
Carbapenemase-producing Enterobacteriaceae (CPE) infections are emerging infections that pose a therapeutic challenge.
These infections mainly occur in patients with prolonged hospitalization and repeated exposure to antibiotics.
Certain strains, notably VIM-producing strains, may remain sensitive to carbapenems.
CPE VIM strains are rare in France, but represent the main CPE strains in many countries.
They are historically the main type of carbapenemases isolated at the Strasbourg University Hospital.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The circulation of multi-antibiotic-resistant bacterial strains is significant at the Strasbourg University Hospital and the investigators wish to report their local experience in the use of carbapenems in infections with enterobacteria producing carbapenemase type VIM.
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Baptiste HOELLINGER, MD
- Phone Number: 33 3 69 55 05 45
- Email: baptiste.hoellinger@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67091
- Recruiting
- Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
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Contact:
- Baptiste HOELLINGER, MD
- Phone Number: 33 3 69 55 05 45
- Email: baptiste.hoellinger@chru-strasbourg.fr
-
Principal Investigator:
- Baptiste HOELLINGER, MD
-
Sub-Investigator:
- Pierre BOYER, MD
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Adult patient (≥18) treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
Description
Inclusion Criteria:
- Adult patient (≥18)
- Treated at the HUS for a VIM-producing enterobacteria infection between 01/01/2011 and 11/30/2022
- Subjects who have not expressed their opposition to the reuse of their data for scientific research purposes.
Exclusion Criteria:
- Patient having expressed his opposition to the retrospective reuse of his data for scientific research purposes.
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 |
---|---|
Mortality at 28 days
Time Frame: Mortality at 28 days after infection
|
Mortality at 28 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)
November 21, 2022
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
December 14, 2023
First Submitted That Met QC Criteria
December 14, 2023
First Posted (Actual)
December 29, 2023
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 14, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8779 (The Newcastle upon Tyne Hospitals NHS FT)
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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