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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: |
NCT00151606 |
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Date of registration:
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08/09/2005 |
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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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Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
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Scientific title:
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Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units. |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00151606 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Christophe Camus, 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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Rennes University Hospital |
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Name:
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Eric Bellissant, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rennes University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults over 18 years
- Expected length of stay > 48h in intensive care unit
- Informed written consent
Exclusion Criteria:
- Cerebral death
- Care limitation
- Neutropenia
- Documented MRSA on admission
- Patients receiving antistaphylococcal topical antibiotics on admission
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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MRSA Colonization
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Nosocomial Infections
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Intervention(s)
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Procedure: Reinforced isolation + Muciprocine
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Primary Outcome(s)
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Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
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Secondary Outcome(s)
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- Additional cost due to reinforced isolation protocol
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- Rate of nosocomial infections due to other pathogens
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- Antistaphylococcal antibiotics use in both protocols
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- Rate of nosocomial infections according to the site
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- Death rate at the exit of intensive care unit
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- Number of days of antibiotherapy
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- Rate of nosocomial MRSA infections
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- Time and cause of septic isolation
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Secondary ID(s)
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AFSSAPS 020551
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CIC0203/010
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PHRC/01-07
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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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