NCT00150852

Brief Summary

The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

December 29, 2005

Status Verified

September 1, 2005

First QC Date

September 6, 2005

Last Update Submit

December 28, 2005

Conditions

Wound Infection

Keywords

GastrostomyWound infectionAntibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Additional costs and nursing charges (Programme de Recherche en Nursing (PRN) scoring system)

Interventions

VancomycinDRUG

Eligibility Criteria

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

You may qualify if:

  • PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Universitaire (CHU)

Grenoble, 38000, France

NOT YET RECRUITING

Division of Gastroenterology, University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Alain Vonlaufen, MD

    Division of Gastroenterology, University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Vonlaufen, MD

CONTACT

+41 22 372 93 40Alain.Vonlaufen@hcuge.ch

Philippe De Saussure, MD

CONTACT

+ 41 22 372 93 40Philippe.deSaussure@hcuge.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

September 1, 2004

Last Updated

December 29, 2005

Record last verified: 2005-09

Locations

CH(2)FR(1)