Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study
NCT ID: NCT00826670
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2009-06-30
2012-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Topical decolonization
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
Placebo (Decolonization)
Placebo
Interventions
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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 (Decolonization)
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Stephen Harbarth
Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection
Locations
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Geneva Universits Hospitals
Geneva, , Switzerland
Countries
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References
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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.
Other Identifiers
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08-161
Identifier Type: -
Identifier Source: org_study_id