跳至主要内容
临床试验/NCT01591538
NCT01591538已完成不适用

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

Da Volterra1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2012年3月最近更新:
适应症

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

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)

研究者

发起方
Da Volterra
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Multi-Antibiotic Resistance Carriage in Gut Flora | 临床试验