Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 525
- 试验地点
- 1
- 主要终点
- Rate of CARB-NS isolates and among them the proportion of those producing CARBase.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •the patient with digestive ER-CARB
结局指标
主要结局
Rate of CARB-NS isolates and among them the proportion of those producing CARBase.
时间窗: 1 year
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.
次要结局
- Impact of the use of the phenotypic algorithm on the management of the patients identified as carrier of NS-CARB isolate.(1 year)
- Detection of CARBase producing isolates as a measure of the diagnostic value of the phenotypic algorithm(1 year)