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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Enterobacteria Susceptible to Carbapenem Carrier
Enterobacteria Non Susceptible to Carbapenem Carrier

Study type

Observational

Funder types

Other

Identifiers

NCT02127450
NI 12025

Details and patient eligibility

About

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.

Full description

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.

Enrollment

525 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

525 participants in 3 patient groups

Case: NS-CARB positive
Description:
Patient with a clinical sample positive for a NS-CARB Enterobacteriaceae
Control 1: non-NS-CARB positive
Description:
Patient with clinical sample positive for a non-NS-CARB Enterobacteriaceae
Control 2 : negative sample
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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