AzTrials
AzTrials

Infection With Beta-lactam Resistance in EnterobacteriaceaeCARBAFRESTNCT02803710

Prevalence of Enterobacteria With Decreased Susceptibility to Carbapenems in Eastern Inter- Region

An observational study of Infection With Beta-lactam Resistance in Enterobacteriaceae, run by CHU de Reims at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass by these enzymes which makes the molecules of last resort in serious infection. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Microbiological study
How many people
315 participants
Where
1 siteFrance
Study dates
Jan 2012to Dec 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: For one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM) (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the Reims University Hospital. Among these strains 105 are randomly selected. The clinical study is conducted as follow: for each patient with CDSE isolate included in a center, 2 control patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.

Who may be able to join

  • Cases: patients (infected or colonized) with an Enterobacteriaceae isolate with decreased susceptibility to carbapenems
  • Controls: patients (infected or colonized) with an Enterobacteriaceae isolate not having reduced susceptibility to carbapenems and for which the strain was isolated following an Enterobacteriaceae isolate with decreased susceptibility to carbapenems (2 controls per case).

Who cannot join

  • <18yo

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Reims

    Reims, 51092

Other trials in France

About this study

Official title: Prevalence of Enterobacteriaceae With Decreased Susceptibility to Carbapenems in Eastern Inter- Region

Upon penicillins' introduction, inactivation of beta- lactam antibiotics by enzymes produced by bacteria was demonstrated. Until recently, carbapenems were a relatively spared subclass by these enzymes which makes the molecules of last resort in serious infection. Recently the prevalence of enzymes hydrolysing carbapenem, the carbapenemases, was increasing in some countries. But these carbapenemases are not the only mechanism involved in a decreased susceptibility to carbapenems which is sometimes linked to the conjunction of several resistance mechanisms. Data available on the epidemic situation of this new resistance are essential for improving their detection, the management of infections in patients and prevent the occurrence of epidemic. In this context, the investigators propose a study in the North-East inter-region to estimate the prevalence of Enterobacteriaceae with decrease susceptibility to carbapenems and look for risk factors for infection with this type of bacteria. The study is conducted in five teaching hospitals (Besançon, Dijon, Nancy, Reims and Strasbourg) and two general hospitals (Colmar and Troyes) in North-Eastern France. For one year, all the Enterobacteriaceae isolates with a decreased susceptibility to carbapenems (CDSE) according to the 2012 Antibiogram Comity of the French Microbiology Society (CA-SFM) (MIC of ertapenem > 0.5 μg/mL) are collected and sent to the bacteriology laboratory of the Reims University Hospital. Among these strains 105 are randomly selected. The clinical study is conducted as follow: for each patient with CDSE isolate included in a center, 2 control patients are selected. They are the patients having the 2 Enterobacteriaceae isolates, with no reduced susceptibility to carbapenems and following the CDSE isolate in the same center.

Microbiological study : identification of isolates is performed using MALDI-TOF (Bruker Daltonics, Bremen, Germany). Antibiotic susceptibilities is determined by the disc diffusion method according to European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines (www.EUCAST.org) and extended-spectrum beta-lactamase (ESBLs) are detected by the double-disc synergy test and carbapenem minimal inhibitory concentrations (MICs to Imipenem, Ertapenem, Doripenem and Meropenem) determined using E-test® strips. Metallo-β-lactamase production was screened with the MβL Etest (bioMérieux, Marcy l'Etoile, France). Beta-lactamases detected using polymerase chain reaction (PCR). Carbapenemase-encoding genes (blaKPC, blaVIM, blaIMP, blaNDM, blaOXA-23-like, blaOXA-24-like, blaOXA-58-like and blaOXA-48-like) were screened using multiplex PCRs and blaIMI and blaGES with simplex PCRs. All the blaOXA-48-like detected were subsequently sequenced. Genes blaTEM, blaSHV, blaCTX-M and blaOXA were detected by PCR using specific primers. Plasmid-mediated AmpC-type genes blaACC, blaFOX, blaMOX, blaDHA, blaCMY and blaMIR were screened using multiplex PCRs. All the beta-lactamases are sequenced. Mutations in the quinolone resistance determining region (QRDR) are identified by PCR and sequencing in the gyrA, gyrB, parC and parE genes. Qnr and qepA genes are detected by real-time PCR, aac(6')-Ib-cr by pyrosequencing and oqxAB by conventional PCR. Genotyping is performed with pulsed-field gel electrophoresis (PFGE) and multilocus sequence typing (MLST).

Read more

Statistical analysis : qualitative variables are analysed with the Chi2 test and the two-tailed Fisher exact test. Quantitative variables are compared using the Mann-Whitney test. Then, a multivariate analysis is conducted: logistic regression with stepwise factors as explanatory variables with p <0.20 in the univariate analysis as input threshold and output set at 0.20.The results are considered statistically significant when P < 0.05.

Expected results : this study will give the proportion of the different species involved, of the carbapenemase in comparison to the other mechanisms, the level of resistance in MIC. Risk factors such as previous antibiotic treatment, underlying disease severity or clonal strain transmission will be evidenced, allowing to identify prevention control measure to implement.

Being tested
Microbiological study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microbiological studyOther

Study groups in NCT02803710
Study groupRoleWhat they receive
Case grouppatients with decreased susceptibility to carbapenems Enterobacteriaceae isolate
Receives: Other: Microbiological study
Control-grouppatients with Enterobacteriaceae isolate without decreased susceptibility to carbapenems
Receives: Other: Microbiological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibiotic susceptibilities by the disc diffusion method

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2012
  4. Study completionDec 2016 (estimated)

Resources

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
Case-control
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02803710
Sponsor's protocol ID
PR11006
Acronym
CARBAFREST
Status last verified
Jun 2016
First submitted
8 Jun 2016
Last updated
20 Jun 2016
Results posted
No

Publications

  • Guillard T, Cholley P, Limelette A, Hocquet D, Matton L, Guyeux C, Lebreil AL, Bajolet O, Brasme L, Madoux J, Vernet-Garnier V, Barbe C, Bertrand X, de Champs On Behalf Of CarbaFrEst Group C. Fluoroquinolone Resistance Mechanisms and population structure of Enterobacter cloacae non-susceptible to Ertapenem in North-Eastern France. Front Microbiol. 2015 Oct 23;6:1186. doi: 10.3389/fmicb.2015.01186. eCollection 2015.

    PubMed 26557115
  • Liapis E, Pantel A, Robert J, Nicolas-Chanoine MH, Cavalie L, van der Mee-Marquet N, de Champs C, Aissa N, Eloy C, Blanc V, Guyeux C, Hocquet D, Lavigne JP, Bertrand X; ONERBA. Molecular epidemiology of OXA-48-producing Klebsiella pneumoniae in France. Clin Microbiol Infect. 2014 Dec;20(12):O1121-3. doi: 10.1111/1469-0691.12727. Epub 2014 Jul 29.

    PubMed 24942039

Questions about this trial

What is this clinical trial studying?

An observational study of Infection With Beta-lactam Resistance in Enterobacteriaceae, run by CHU de Reims at 1 site 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: status not confirmed, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Antibiotic susceptibilities by the disc diffusion method (time frame: 12 months). 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 NCT02803710, which also lists 2 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 20 Jun 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in