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临床试验/NCT02058888
NCT02058888已完成不适用

Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.

研究概览

简要总结

The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming. Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore contribute to the observed trend. Differences in the degree of selection pressure caused by various antimicrobials have not been systematically investigated until today. The aim of the proposed project is the determination of the impact of antibiotic treatment on the copy number of resistance genes in the human intestinal microbiome using metagenome shotgun sequencing. The resistance gene count in the gastrointestinal tract will be determined in a clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as monotherapy. The subsequent quantification and comparison of the selection pressure facilitates the application of antibiotics with a lower potential to select for resistance. To achieve this goal, a self-controlled, prospective observational epidemiological study will be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).

研究设计

研究类型
Observational
观察模型
Other
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

  • male or female patients ≥ 18 years
  • patients with acute leukaemia
  • admission to one of the 2 study centres
  • obtained written consent

排除标准

  • treatment with antibiotics in the previous 30 days
  • pregnancy
  • patients currently treated for HIV and/or hepatitis b/c
  • patients who can not estimate scope and consequences of their participation in the study
  • patients who will most likely not be able to follow the study protocol

结局指标

主要结局

Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.

时间窗: day 0, day 1, day 3, end of antimicrobial treatment

Stool samples will be collected from patients at four time points: t0 (baseline) The time point serves as a control. The stool sample will be obtained before treatment start. t1 (early phase) The time point reflects the early phase at day 1 of treatment with either ciprofloxacin or cotrimoxazol. t2 (early-late phase) The time point reflects the early-late phase at day 3 of treatment. t3 (late phase) The time point reflects the end of treatment (max. day 7).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Matthias Willmann

MD, MSc, DTM&H

University Hospital Tuebingen

研究点 (1)

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