Clinical Trials Directory

Trials / Completed

CompletedNCT00151606

Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
500 (planned)
Sponsor
Rennes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREReinforced isolation + Muciprocine

Timeline

Start date
2002-12-01
Completion
2004-02-01
First posted
2005-09-09
Last updated
2006-01-10

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT00151606. Inclusion in this directory is not an endorsement.