Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
Procedure: Reinforced isolation + Muciprocine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.|
- Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
- - Rate of nosocomial MRSA infections
- - Rate of nosocomial infections due to other pathogens
- - Rate of nosocomial infections according to the site
- - Death rate at the exit of intensive care unit
- - Additional cost due to reinforced isolation protocol
- - Antistaphylococcal antibiotics use in both protocols
- - Number of days of antibiotherapy
- - Time and cause of septic isolation
|Study Start Date:||December 2002|
|Estimated Study Completion Date:||February 2004|
Recommendations for the prevention of transmission of resistant bacteria in intensive care units (ICU) are rarely based on controlled trials. For this reason, we compared a reinforced isolation precautions protocol (RIPP) with a standard precautions protocol (SPP) for the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) in 2 intensive care units.
Evaluation: the risk for MRSA carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of MRSA in the 5 past years.
Intervention: Randomization 1/1 of a total of 500 patients to either protocol; MRSA screening was performed at the sites of carriage and colonization at inclusion, every week and at ICU discharge in all patients; the results were given to the clinicians only for the patients of the RIPP group.
Protocols: the SPP was consistent with the CDC recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including MRSA) or highly transmissible organisms. The RIPP included the extension of isolation precautions (1) to patients at risk for MRSA on admission until screening results proved negative and (2) to MRSA-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. Compliance with the recommendations of each protocol was controlled by an audit.
The efficacy is assessed on the proportion of patients who acquired MRSA at any site.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151606
|Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou|
|Rennes, France, 35033|
|Service de Réanimation Médicale - Hôpital Bretonneau|
|Tours, France, 37000|
|Principal Investigator:||Christophe Camus, MD||Rennes University Hospital|
|Study Chair:||Eric Bellissant, MD, PhD||Rennes University Hospital|