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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00150852 |
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Date of registration:
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06/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.
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Scientific title:
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Vancomycin for Prophylaxis of PEG-Related Wound Infection in MRSA-Positive Patients: a Double-Blind, Randomized, Placebo-Controlled Study |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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96 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00150852 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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France
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Switzerland
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Contacts
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Name:
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Alain Vonlaufen, MD |
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Address:
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Telephone:
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+41 22 372 93 40 |
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Email:
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Alain.Vonlaufen@hcuge.ch |
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Affiliation:
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Name:
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Alain Vonlaufen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology, University Hospital, Geneva |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding
PEG insertion
Exclusion Criteria:
- Age < 18 years
- No informed consent obtained either from the patient or from his legal representative
- Contraindication to the administration of cefazolin or of vancomycin
- Systemic administration of antibiotics effective against MRSA during the week prior
to the procedure
- Technique of PEG insertion different from the standard pull technique proposed by the
physician in charge and the gastroenterologist
- Patients requiring antibiotic prophylaxis of endocarditis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Wound Infection
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Intervention(s)
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Drug: Vancomycin
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Primary Outcome(s)
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Rate of PEG-site infection at 3, 7, 14, 21 and 28 days post intervention as assessed by a clinical score (Jain score) and swab culture
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Secondary Outcome(s)
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Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)
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Secondary ID(s)
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04-012 (med 04-008)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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