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

Primary Purpose

Enterobacteriaceae Infections

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Decolonization
Placebo (Decolonization)
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Enterobacteriaceae Infections focused on measuring Antibiotic resistance, ESBL carriage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva Universits Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topical decolonization

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 20, 2009
Last Updated
August 6, 2012
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00826670
Brief Title
Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterobacteriaceae Infections
Keywords
Antibiotic resistance, ESBL carriage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical decolonization
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Decolonization
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo (Decolonization)
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Geneva Universits Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23719234
Citation
Huttner B, Haustein T, Uckay I, Renzi G, Stewardson A, Schaerrer D, Agostinho A, Andremont A, Schrenzel J, Pittet D, Harbarth S. Decolonization of intestinal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae with oral colistin and neomycin: a randomized, double-blind, placebo-controlled trial. J Antimicrob Chemother. 2013 Oct;68(10):2375-82. doi: 10.1093/jac/dkt174. Epub 2013 May 29.
Results Reference
derived

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

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