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
  Purpose

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.


Condition Intervention
Nosocomial Infections
MRSA Colonization
Procedure: Reinforced isolation + Muciprocine

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.

Secondary Outcome Measures:
  • - 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

Estimated Enrollment: 500
Study Start Date: December 2002
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151606

Locations
France
Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou
Rennes, France, 35033
Service de Réanimation Médicale - Hôpital Bretonneau
Tours, France, 37000
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Christophe Camus, MD Rennes University Hospital
Study Chair: Eric Bellissant, MD, PhD Rennes University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00151606     History of Changes
Other Study ID Numbers: AFSSAPS 020551, PHRC/01-07, CIC0203/010
Study First Received: September 8, 2005
Last Updated: January 9, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Infection prevention
Isolation
Resistant bacteria
MRSA colonization

Additional relevant MeSH terms:
Infection
Staphylococcal Infections
Cross Infection
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014