Clinical trial NCT02127450: Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
Official title: Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteria Non Susceptible to Carbapenem Carrier
Enterobacteria Susceptible to Carbapenem Carrier
Keywords: Enterobacteriaceae
non-susceptible to carbapenem
carbapenemases
prevalence
screening algorithm
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 525
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patient hospitalised for more than 24 hours , with a clinical sample positive for a NS-CARB Enterobacteriaceae
* Patient hospitalised for more than 24 hours with clinical sample positive for a non-NS-CARB Enterobacteriaceae and hospitalised in the same type of ward as that case
* Patient hospitalised for more than 24 hours 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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of CARB-NS isolates and among them the proportion of those producing CARBase.
timeFrame: 1 year
Secondary outcomes:
measure: Detection of CARBase producing isolates as a measure of the diagnostic value of the phenotypic algorithm
timeFrame: 1 year
measure: Impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate.
timeFrame: 1 year
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-Hélène Nicolas-Chanoine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: