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临床试验/NCT03140826
NCT03140826已完成不适用

Amplification and Selection of Antimicrobial Resistance in the Intestine II

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Antibiotic Selection Pressure

研究概览

简要总结

Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.

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

  • Patients with hemato-oncological disease in neutropenia or with expected neutropenia
  • Need for treatment with meropenem or piperacillin-tazobactam

排除标准

  • pregnancy
  • HIV, HBV, HCV

研究组 & 干预措施

Meropenem arm

Patients receiving meropenem to treat an infection.

干预措施: meropenem (Drug)

结局指标

主要结局

Antibiotic Selection Pressure

时间窗: under treatment, max. 10 days

Degree of the change of the intestinal resistome.

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

Prof. Dr. med.

University Hospital Tuebingen

研究点 (2)

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