跳至主要内容
临床试验/NCT01209247
NCT01209247已完成不适用

Emergence of Fluoroquinolone Resistance in the Commensal Flora of Patients Receiving Fluoroquinolone Treatment.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 571 人开始时间: 2010年10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
571
试验地点
1
主要终点
emergence of fluoroquinolone-resistance

研究概览

简要总结

The emergence of resistance to fluoroquinolone (FQ) 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 rectal, nasal and pharyngeal flora will be collected from hospitalized patients before receiving a FQ, at the end of the treatment and 1 month after the end of treatment. Clinical data will be collected. The incidence and risk-factors associated with the emergence of resistance to FQ will be assessed by comparing groups with and without resistance both at the end of treatment and 1 month later.

详细描述

Population involved: Patients hospitalized (>1day) in one of the two participating university hospitals and receiving a treatment by a fluoroquinolone (FQ) antibiotic.

Number of centers : 2 (SAINT LOUIS and BEAUJON Hospitals, ASSISTANCE PUBLIQUE HOPITAUX DE PARIS, Paris, France).

Expected number of patients : 720

Aim : To study the incidence and risk-factors involved in the emergence of resistance to FQ in the commensal flora during and after treatment by a FQ.

Methods: Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment. Microbiological analysis will focus on 3 target bacterial species: Escherichia coli from the faecal flora, alpha-haemolytic streptococci from the pharyngeal flora and non-coagulase staphylococci in the nasal flora. Patients carrying resistance at day 0 in all three flora will be excluded. The incidence and risk-factors of the emergence of resistance to FQ will be assessed at the end of treatment by FQ and 1 month after the end of treatment. Patients having resistant bacteria in their flora at the end and/or after treatment will be compared with those with no resistance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Hospitalisation >24hours in one of the participating wards Treatment by a fluoroquinolone antibiotic.

排除标准

  • Pregnancy or breast feeding Patients refusal to participate

结局指标

主要结局

emergence of fluoroquinolone-resistance

时间窗: 4 months

To know the incidence and describe risk-factors involved in the emergence of fluoroquinolone-resistance in the commensal flora of patients treated by a fluoroquinolone.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验