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临床试验/NCT07424989
NCT07424989已完成不适用

Antibiotic Therapies for Urinary Tract Infections and Their Impact on the Gut Microbiota

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年7月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.

研究概览

简要总结

A urinary tract infection requires antibiotic treatment. While this treatment is intended to eliminate bacteria from the urine, it may also facilitate the development of resistant strains in the digestive tract. Patients are asked to provide stool samples on several occasions so that any potential side effects of this treatment on the digestive flora can be analysed.

详细描述

Each of us has billions of bacteria in our intestines that aid digestion (scientifically known as the gut microbiota), some of which can "mutate", i.e. adapt to resist antibiotics. Although this is usually harmless, these bacteria can sometimes cause infections.

Hence the importance of better understanding this phenomenon, known as the 'collateral effect on flora of otherwise beneficial antibiotic treatment'. The investigators already know that not all antibiotics are equivalent, with some having a stronger 'collateral effect'. However, the risk classification remains poorly understood.

Recent advances in laboratory stool analysis now make it possible to better analyse this phenomenon.

The ultimate goal is to identify treatment regimens that are both highly effective in treating urinary tract infections and have the least possible ecological impact.

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

  • Adult patient requiring hospitalisation
  • Diagnosis of urinary tract infection requiring systemic antibiotic therapy with ceftriaxone, piperacillin/tazobactam or temocillin
  • Collection of a stool sample possible before or within 24 hours of starting systemic antibiotic therapy
  • Patient who has read and understood the information letter and given their consent to participate in the research

排除标准

  • Minor patient
  • Patient hospitalised in an intensive care unit
  • Digestive stoma
  • Patient not affiliated with social security
  • Pregnant woman, woman in labour or breastfeeding woman
  • Person deprived of liberty by administrative or judicial decision
  • Person placed under judicial protection, guardianship or curatorship

结局指标

主要结局

Assessing the alteration of the gut microbiota induced by initial antibiotic therapy for urosepsis.

时间窗: From enrollment to 30-35 days after the end of antibiotic treatment

Impact of initial antibiotic therapy on the increase in EC3GR enteric carriage defined as: * Positive EC3GR culture in stool sample 30-35 days after the end of antibiotic treatment (FT+30-35) in a patient with a negative (i.e. undetectable) EC3GR culture in stool sample on day 0 (D0) * Or a tenfold increase in the relative abundance of EC3GR between stool samples taken on D0 and FT-30-35 in patients with a positive EC3GR culture in stool samples taken on D0

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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