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

Sponsor:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00826670

Purpose

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.

Condition	Intervention	Phase
Enterobacteriaceae Infections	Drug: Decolonization Drug: Placebo (Decolonization)	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Topical decolonization: Experimental	Drug: Decolonization 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: Placebo Comparator	Drug: Placebo (Decolonization) Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826670

Contacts

Contact: Benedikt Huttner, MD

41223729828

benedikt.huttner@hcuge.ch

Locations

Switzerland
CHUV	Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Giorgio Zanetti, MD
Geneva Universits Hospitals	Recruiting
Geneva, Switzerland, 1211
Contact: Stephan Harbarth, MD MS 41223723311 stephan.harbarth@hcuge.ch
Principal Investigator: Stephan Harbarth, MD MS

Sponsors and Collaborators

University Hospital, Geneva

More Information

No publications provided

Responsible Party:	Geneva University Hospitals and Medical School ( Dr Stephan Harbarth )
Study ID Numbers:	08-161
Study First Received:	January 20, 2009
Last Updated:	October 7, 2009
ClinicalTrials.gov Identifier:	NCT00826670 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Antibiotic resistance
ESBL carriage

Additional relevant MeSH terms:

Bacterial Infections
Enterobacteriaceae Infections
Infection
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on February 08, 2010