NCT02799225

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

June 10, 2016

Last Update Submit

April 22, 2026

Conditions

Keywords

carbapenems

Outcome Measures

Primary Outcomes (1)

  • prevalence of clinical strains of Enterobacteria

    1 year

Secondary Outcomes (1)

  • characterization of the mechanisms responsible for carbapenems resistance

    1 year

Study Arms (1)

Enterobacteria

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing bacteriological samples as part of routine clinical practice during their hospital stay in one of the 6 participating centres. Patients in whom the results of bacteriological examinations reveal the presence of an Enterobacteria strain with reduced susceptibility to carbapenems will be included in this project

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CH Abbeville

Abbeville, 80142, France

Location

CHU Amiens

Amiens, 80054, France

Location

CH Beauvais

Beauvais, 60021, France

Location

CHU Caen

Caen, 14033, France

Location

CHU Compiegne

Compiègne, 60321, France

Location

CHRU Lille

Lille, 59037, France

Location

Related Publications (3)

  • 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 Officials

  • Hedi MAMMERI, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 14, 2016

Study Start

June 1, 2012

Primary Completion

February 2, 2014

Study Completion

February 2, 2014

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations