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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

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 ]

Enrollment: 58
Study Start Date: June 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical decolonization 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 Comparator: Placebo 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
Geneva Universits Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephen Harbarth, Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00826670     History of Changes
Other Study ID Numbers: 08-161
Study First Received: January 20, 2009
Last Updated: August 6, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Antibiotic resistance
ESBL carriage

Additional relevant MeSH terms:
Enterobacteriaceae Infections
Bacterial Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on October 20, 2014