Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT02127450
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-CARB
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: