NCT00826670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

3.2 years

First QC Date

January 20, 2009

Last Update Submit

August 6, 2012

Conditions

Enterobacteriaceae Infections

Keywords

Antibiotic resistanceESBL carriage

Outcome Measures

Primary Outcomes (1)

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

    28 days

Study Arms (2)

Topical decolonization

EXPERIMENTAL
Drug: Decolonization

Placebo

PLACEBO COMPARATOR
Drug: Placebo (Decolonization)

Interventions

DecolonizationDRUG

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

Topical decolonization
Placebo (Decolonization)DRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Universits Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 23719234DERIVED

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

CH(1)