EnterobacteriaceaeERCNCT02799225
Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
An observational study of Enterobacteriaceae, run by Centre Hospitalier Universitaire, Amiens at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Enterobacteriaceae
- How many people
- 287 participants
- Where
- 6 sitesFrance
- Study dates
- Jun 2012to 2 Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Abbeville
Abbeville, 80142
CHU Amiens
Amiens, 80054
CH Beauvais
Beauvais, 60021
CHU Caen
Caen, 14033
CHU Compiegne
Compiègne, 60321
CHRU Lille
Lille, 59037
About this study
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.
- Conditions
- Enterobacteriaceae
- Keywords
- carbapenems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enterobacteria | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of clinical strains of Enterobacteria
Measured: 1 year
Secondary outcomes (1)
characterization of the mechanisms responsible for carbapenems resistance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2012
- Primary completion2 Feb 2014
- Study completion2 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EnterobacteriaceaeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hedi MAMMERI, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799225
- Sponsor's protocol ID
- PHRCIR11-DR-MAMMERI
- Acronym
- ERC
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2016
- Last updated
- 27 Apr 2026
- Results posted
- No
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.
PubMed 28264855Dupont 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.
PubMed 26482307Ammenouche 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.
PubMed 25136020
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Clinical Strains of Enterobacteria With Reduced Susceptibility to Carbapenems in the North-West Region of France
- ClinicalTrials.gov ID
- NCT02799225
- Acronym / sponsor ID
- ERC / PHRCIR11-DR-MAMMERI
- Conditions
- Enterobacteriaceae
- Keywords
- carbapenems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 2 Feb 2014 (actual)
- Study completion
- 2 Feb 2014 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enterobacteria | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of clinical strains of Enterobacteria
Time frame: 1 year
1 secondary outcome
characterization of the mechanisms responsible for carbapenems resistance
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 28264855Dupont 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.
- Results publication: PubMed 26482307Dupont 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.
- Results publication: PubMed 25136020Ammenouche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedi MAMMERI, PhD principal investigator
CHU Amiens
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterobacteriaceae, run by Centre Hospitalier Universitaire, Amiens at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of clinical strains of Enterobacteria (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799225, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.