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Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases

NCT ID: NCT02127450

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in the routine in any laboratory is difficult. it will be useful to standardize them detection to control the emergence.

Detailed Description

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The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy because CARBA are often the alone antibiotics available to cure severe infections due to extended-spectrum β-lactamase (ESBL)-producing isolates. Two mechanisms of resistance to CARBA have been identified: membrane impermeability associated with ESBL or cephalosporinase production and carbapenemase (CARBase) production. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital in order to avoid the dissemination of the CARBase-producing strain and insure patient safety. Prevalence rate of non-susceptible (NS) isolates to CARB, the proportion of the two types of mechanisms of resistance to CARB and the factors associated with CARB- NS isolates are still unknown in France. Moreover, detecting CARBase in the routine in any laboratory is difficult. Providing data regarding all of these points will be useful for any hospital and will permit to optimize the management of the patients suspected or proved to harbor a CARBase-producing Enterobacteriaceae isolate.

Conditions

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Enterobacteria Non Susceptible to Carbapenem Carrier Enterobacteria Susceptible to Carbapenem Carrier

Keywords

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Enterobacteriaceae non-susceptible to carbapenem carbapenemases prevalence screening algorithm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case: NS-CARB positive

Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae

No interventions assigned to this group

Control 1: non-NS-CARB positive

Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae

No interventions assigned to this group

Control 2 : negative sample

Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Case: Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae
* Control 1: Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case
* Control 2: Patient having had clinical sample(s) being stayed negative since the beginning of his admission and up to 3 days after the detection of the case, hospitalised in any type of ward in the hospital

Exclusion Criteria

* the patient with digestive ER-CARB
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Hélène Nicolas-Chanoine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Beaujon

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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NI 12025

Identifier Type: -

Identifier Source: org_study_id