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

January 20, 2009
August 6, 2012
June 2009
August 2012   (final data collection date for primary outcome measure)
Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00826670 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Enterobacteriaceae Infections
  • 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
  • Experimental: Topical decolonization
    Intervention: Drug: Decolonization
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (Decolonization)
Huttner B, Haustein T, Uçkay I, Renzi G, Stewardson A, Schaerrer D, Agostinho A, Andremont A, Schrenzel J, Pittet D, Harbarth S. Decolonization of intestinal carriage of extended-spectrum β-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00826670
08-161
No
Stephen Harbarth, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Not Provided
University Hospital, Geneva
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP