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Trial record 45 of 61 for:    Neomycin sulfate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00826670
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
Stephen Harbarth, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Enterobacteriaceae Infections Drug: Decolonization Drug: Placebo (Decolonization) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : June 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00826670

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Geneva Universits Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stephen Harbarth, Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection, University Hospital, Geneva Identifier: NCT00826670     History of Changes
Other Study ID Numbers: 08-161
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012

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

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