Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
Information source: University Hospital, Geneva
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Enterobacteriaceae Infections
Intervention: Decolonization (Drug); Placebo (Decolonization) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Geneva Overall contact:
Benedikt Huttner, MD, Phone: 41223729828, Email: benedikt.huttner@hcuge.ch
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.
Clinical Details
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients can be enrolled into the study provided that all of the following criteria are
met:
1. Microbiologically documented rectal carriage of ESBL-producing Enterobacteriaceae,
without signs and symptoms of active infection with ESBL-producing Enterobacteriaceae
at any body site
2. 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:
1. Women who are pregnant or nursing
2. Active infection
3. Treatment with antimicrobial agents with activity against ESBL-producing
Enterobacteriaceae
4. Contraindication to the use of one of the study drugs (e. g. renal insufficiency with
creatinine clearance < 30 ml/min)
5. Patient already enrolled in another study, or in the present study for a previous
episode
6. Psychiatric disorder or unable to understand or to follow the protocol directions
7. Permanent indwelling urinary catheter that can not be changed
8. Resistance of the ESBL-producing Enterobacteriaceae to one of the study drugs
9. Known hypersensitivity to one of the study drugs
Locations and Contacts
Benedikt Huttner, MD, Phone: 41223729828, Email: benedikt.huttner@hcuge.ch
CHUV, Lausanne 1011, Switzerland; Not yet recruiting
Giorgio Zanetti, MD
Geneva Universits Hospitals, Geneva 1211, Switzerland; Recruiting
Stephan Harbarth, MD MS, Phone: 41223723311, Email: stephan.harbarth@hcuge.ch
Stephan Harbarth, MD MS, Principal Investigator
Additional Information
Starting date: June 2009
Ending date: September 2010
Last updated: October 7, 2009
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