Clinical Trial: Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

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.

Detailed Summary:
Sponsor: University Hospital, Geneva

Current Primary Outcome: Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Geneva

Dates:
Date Received: January 20, 2009
Date Started: June 2009
Date Completion:
Last Updated: August 6, 2012
Last Verified: August 2012