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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00151606
Enrollment
500
Registered
2005-09-09
Start date
2002-12-31
Completion date
2004-02-29
Last updated
2006-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRSA Colonization, Nosocomial Infections

Keywords

Infection prevention, Isolation, Resistant bacteria, MRSA colonization

Brief 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.

Interventions

PROCEDUREReinforced isolation + Muciprocine

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.

Secondary

MeasureTime frame
- 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
- Rate of nosocomial MRSA infections
- Antistaphylococcal antibiotics use in both protocols
- Number of days of antibiotherapy
- Time and cause of septic isolation
- Additional cost due to reinforced isolation protocol

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026