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

NCT02127450 | Completed DMC

• 1 other identifier: NI 12025
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterobacteria Non Susceptible to Carbapenem Carrier; Enterobacteria Susceptible to Carbapenem Carrier

Keywords

Enterobacteriaceae; non-susceptible to carbapenem; carbapenemases; prevalence; screening algorithm

Outcome Measures

Primary Outcomes (1)

• Rate of CARB-NS isolates and among them the proportion of those producing CARBase.

  Determining the prevalence rate of CARB-NS isolates and among them the proportion of those producing CARBase for all enterobacterial species and for each species. CARBase production will be determined by using in a phenotypic algorithm previously established on the basis on commercialized tests and by molecular methods. Determining by using a prospective case-control-control study the factors associated with a clinical sample positive for a NS-CARB isolate by distinguishing isolates non-CARBase-producing and isolates CARBase-producing.This study will be carried out during one year in 18 hospitals across France whose laboratory will participate in the prevalence study. The variables independently associated with a clinical sample positive for either a NS-CARB, non-CARBase-producing isolate or a NS-CARB, CARBase-producing isolate will be determined in a multivariate analysis.

  1 year

Secondary Outcomes (2)

• Detection of CARBase producing isolates as a measure of the diagnostic value of the phenotypic algorithm

  1 year

• Impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate.

  1 year

Study Arms (3)

Case: NS-CARB positive

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

Control 1: non-NS-CARB positive

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• the patient with digestive ER-CARB

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Beaujon

Clichy, 92110, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Enterobacteriaceae Isolates non-susceptible to carbapenem (NS -CARB)

Study Officials

• Marie-Hélène Nicolas-Chanoine, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

FR (1)