Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment
研究概览
简要总结
Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. As is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly intestinal and urinary carriage.
To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of ESBL carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. Even if eradication turns out to be impossible, transient suppression of ESBL might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective.
The purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL carriage in hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients can be enrolled into the study provided that all of the following criteria are met:
- •Microbiologically documented rectal carriage of ESBL-producing Enterobacteriaceae, without signs and symptoms of active infection with ESBL-producing Enterobacteriaceae at any body site
- •Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.
排除标准
- •Women who are pregnant or nursing
- •Active infection
- •Treatment with antimicrobial agents with activity against ESBL-producing Enterobacteriaceae
- •Contraindication to the use of one of the study drugs (e.g. renal insufficiency with creatinine clearance < 30 ml/min)
- •Patient already enrolled in another study, or in the present study for a previous episode
- •Psychiatric disorder or unable to understand or to follow the protocol directions
- •Permanent indwelling urinary catheter that can not be changed
- •Resistance of the ESBL-producing Enterobacteriaceae to one of the study drugs
- •Known hypersensitivity to one of the study drugs
研究组 & 干预措施
Topical decolonization
干预措施: Decolonization (Drug)
Placebo
干预措施: Placebo (Decolonization) (Drug)
结局指标
主要结局
Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment
时间窗: 28 days
次要结局
未报告次要终点
研究者
Stephen Harbarth
Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection
University Hospital, Geneva