跳至主要内容
临床试验/NCT02031588
NCT02031588终止不适用

Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
77
试验地点
1
主要终点
Describe the changes in the composition of the gut microbial flora in relation to the initial flora (T0) in patients receiving antibiotics, by date of sampling, treatment received, dose, duration of therapy, ward, and duration of hospital stay.

研究概览

简要总结

Observational study of the effects of antibiotics on commensal flora. Realization of stool samples and nasal swabs before and after antibiotic therapy.

详细描述

The emergence of resistance to fluoroquinolone (FQ) and is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related...) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of digestive flora will be collected from hospitalized patients before receiving a FQ or Ceftriaxone, at the end of the treatment and 3 month after the end of treatment. Clinical data will be collected.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Describe the changes in the composition of the gut microbial flora in relation to the initial flora (T0) in patients receiving antibiotics, by date of sampling, treatment received, dose, duration of therapy, ward, and duration of hospital stay.

时间窗: 1 year

The primary endpoint is the change in composition of the microbial flora in relation to the initial flora (T0), at the exit of the hospital or at the end of treatment if occurs while the patient is still hospitalized (bis T0, T1, T1 bis), 3 months after the end of treatment (T2) and one year after the end of treatment (T3).

次要结局

  • A secondary endpoint is to describe the changes in the gut microbiota of hospitalized patients not receiving antibiotics.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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