Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Geneva

Conditions:

Enterobacteriaceae Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 urinar...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00826670

Start Date

June 1 2009

End Date

August 1 2012

Last Update

August 7 2012

Active Locations (1)

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1

Geneva Universits Hospitals

Geneva, Switzerland, 1211