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

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.

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Key information

Conditions

Enterobacteriaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Geneva Universits Hospitals

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Decolonization

Drug

Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days

plus In the presence of urinary tract colonization choice of one of the following agents (according to susceptibility profile, creatinine clearance and individual contraindications) Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days

Placebo (Decolonization)

Drug

Placebo

Primary outcomes

Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jan 22, 2009
Registry last updated: Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed