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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Stephen Harbarth, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT00826670

First received: January 20, 2009

Last updated: August 6, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 20, 2009
Last Updated Date	August 6, 2012
Start Date ^ICMJE	June 2009
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 20, 2009)	Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00826670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
Official Title ^ICMJE	Not Provided
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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Enterobacteriaceae Infections
Intervention ^ICMJE	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 Drug: Placebo (Decolonization) Placebo
Study Arm (s)	Experimental: Topical decolonization Intervention: Drug: Decolonization Placebo Comparator: Placebo Intervention: Drug: Placebo (Decolonization)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	58
Completion Date	August 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT00826670
Other Study ID Numbers ^ICMJE	08-161
Has Data Monitoring Committee	No
Responsible Party	Stephen Harbarth, University Hospital, Geneva
Study Sponsor ^ICMJE	University Hospital, Geneva
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Geneva
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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