Status:
COMPLETED
Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares
Lead Sponsor:
UMC Utrecht
Conditions:
Hospital Acquired Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactam...
Detailed Description
A cluster-randomized trial with a stepped wedge design will be conducted in adult ICU's throughout Europe The MOSAR-ICU trial is motivated by three primary considerations: 1. Advances in behavioral ...
Eligibility Criteria
Inclusion
- colonization with either MRSA, VRE or ESBL is endemic
- at least one dedicated infection control physician
- ability to obtain, store and analyze surveillance cultures
- at least 8 ICU beds; all of which have possibility for mechanical ventilation
- ability to collect the data required for analysis
- written approval of the institution's IRB
- signed protocol signature page
Exclusion
- burn units
- cardiothoracic units
- pediatric and neonatal ICUs
- ICU is currently using rapid diagnostic testing in their screening program for AMRB
- ICU is planning to enroll subjects in studies testing investigational agents for the purpose of eradicating or preventing colonization with MRSA, VRE or ESBL or devices or practice management strategies that have colonization and/or infection with AMRB as an outcome
- using SOD/ SDD or any topical antimicrobial therapy
- using chlorhexidine body washings
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
14318 Patients enrolled
Trial Details
Trial ID
NCT00976638
Start Date
June 1 2008
End Date
May 1 2011
Last Update
August 6 2012
Active Locations (13)
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1
Hopital Henri Mondor
Créteil, France, 94000
2
Raymond Poincare Hospital
Garches, France, F-92380
3
Hopital Paris Saint Joseph
Paris, France, 75674
4
Laikon General Hospital
Athens, Greece, 11527