Prevalence Study Evaluating the Acquisition of Carriage of Resistant Bacteria in the Gut Flora in Volunteers From French Armed Forces Coming Back From External Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Da Volterra
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France
研究概览
简要总结
Prevalence Study evaluating the acquisition of carriage of multidrug-resistant Gram-negative bacteria (MDRGNB) in the gut flora in volunteers of French Armed Forces staying from 4 to 6 months outside France.
详细描述
Emergence of MDRGN bacteria is blowing worldwide up leading to therapeutical failure in hospitalized patients with severe infections, as well as in outpatients with community-acquired infections such as UTI. Variation in prevalence exists across countries and regions. Travels outside own country of residence, like France, whatever the duration (short or long)or the reason (professional or leisure), are known risk factors for acquiring and disseminating MDRGN bacteria. Digestive carriage of multidrug-resistant Enterobacteriaceae could be a source of infection for the host as well as a source of dissemination. Qualitative and quantitative gut colonization by MDRGNB is poorly studied in non-hospitalized people who stayed for a few months out of France. The total amount of multidrug-resistant Enterobacteriaceae influences the spread of the dissemination. In our knowledge, no clinical study has been carried out to qualify and quantify gut colonization by MDRGNB in volunteers after staying 4-6 months outside country of residence such as France. A specific microbiological method will be evaluated in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being older than 18 years
- •Have given an informed consent by signing the written consent
- •Being able to give a stool sample
- •Being member of military forces, supported medically by the French Military Health Services (SSA), and to participate outside mission during 4- 6 months
排除标准
- •Participating in another biomedical study during the study
- •Volunteer unable to give informed consent.
结局指标
主要结局
Frequency of MDRGNB (ESBLs or carbapenemases) colonization in gut flora of volunteers after staying 4-6 months outside France
时间窗: 12 months
次要结局
- Quantitative measurement of MDRGNB in fecal samples (expressed as log10 and percentage) of volunteers after staying 4-6 months outside France(12 months)
- Quantitative variation of MDRGNB between the departure and return in volunteers(12 months)
- PCR and sequencing of resistance genes from strains of interest(12 months)
- Evaluation of risk factors for acquiring MDRGNB in gut flora of volunteers after staying 4-6 months outside France(12 months)
