- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799225
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France (ERC)
Enterobacteria constitute a family of Gram negative bacilli of the gastrointestinal flora. These micro-organisms are frequently responsible for nosocomial or community-acquired infections, for which treatment is essentially based on the use of beta-lactam antibiotics. This class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems. Carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating enzymes.
However, new enzymes, called carbapenemases, able to confer resistance to carbapenems either alone or in combination with additional resistance mechanisms such as loss of membrane permeability or overexpression of efflux systems, are currently emerging all over the world. Carbapenemases represent a major public health problem because of the risk of therapeutic impasse and their high epidemic potential.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Abbeville, France, 80142
- CH Abbeville
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Amiens, France, 80054
- CHU Amiens
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Beauvais, France, 60021
- CH Beauvais
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Caen, France, 14033
- CHU Caen
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Compiègne, France, 60321
- CHU Compiegne
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Lille, France, 59037
- CHRU Lille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients in whom the results of bacteriological examinations reveal the presence of an Enterobacteria strain with reduced susceptibility to carbapenems
- Control : patients ( infected or colonized ) a strain of Enterobacter sensitive to carbapenems immediately isolated after a strain of Enterobacter having decreased susceptibility to carbapenems from the same service and same hospital ( 2 strains susceptible strain with reduced sensitivity).
Exclusion Criteria:
- Duplicate : same strain to a first strain of reduced sensitivity in isolated the same patient during the study period ( same bacterial species , even after characterization resistance mechanism).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Enterobacteria
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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prevalence of clinical strains of Enterobacteria
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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characterization of the mechanisms responsible for carbapenems resistance
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Hedi MAMMERI, PhD, CHU Amiens
Publications and helpful links
General Publications
- Dupont H, Choinier P, Roche D, Adiba S, Sookdeb M, Branger C, Denamur E, Mammeri H. Structural Alteration of OmpR as a Source of Ertapenem Resistance in a CTX-M-15-Producing Escherichia coli O25b:H4 Sequence Type 131 Clinical Isolate. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e00014-17. doi: 10.1128/AAC.00014-17. Print 2017 May.
- Dupont H, Gaillot O, Goetgheluck AS, Plassart C, Emond JP, Lecuru M, Gaillard N, Derdouri S, Lemaire B, Girard de Courtilles M, Cattoir V, Mammeri H. Molecular Characterization of Carbapenem-Nonsusceptible Enterobacterial Isolates Collected during a Prospective Interregional Survey in France and Susceptibility to the Novel Ceftazidime-Avibactam and Aztreonam-Avibactam Combinations. Antimicrob Agents Chemother. 2015 Oct 19;60(1):215-21. doi: 10.1128/AAC.01559-15. Print 2016 Jan.
- Ammenouche N, Dupont H, Mammeri H. Characterization of a novel AmpC beta-lactamase produced by a carbapenem-resistant Cedecea davisae clinical isolate. Antimicrob Agents Chemother. 2014 Nov;58(11):6942-5. doi: 10.1128/AAC.03237-14. Epub 2014 Aug 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRCIR11-DR-MAMMERI
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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