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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00151606
First received: September 8, 2005
Last updated: January 9, 2006
Last verified: January 2006

September 8, 2005
January 9, 2006
December 2002
Not Provided
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Same as current
Complete list of historical versions of study NCT00151606 on ClinicalTrials.gov Archive Site
  • - 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
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Nosocomial Infections
  • MRSA Colonization
Procedure: Reinforced isolation + Muciprocine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
February 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00151606
AFSSAPS 020551, PHRC/01-07, CIC0203/010
Not Provided
Not Provided
Rennes University Hospital
Ministry of Health, France
Principal Investigator: Christophe Camus, MD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD Rennes University Hospital
Rennes University Hospital
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP