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

This study has been completed.

Sponsors and Collaborators: Rennes University Hospital
French Ministry of Health
Information provided by: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00151606

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further Study Details: 
Primary Outcomes: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Secondary Outcomes: - 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
Expected Total Enrollment:  500

Study start: December 2002;  Study completion: September 2005
Last follow-up: February 2004;  Data entry closure: July 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

Location Information


France
      Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou, Rennes,  35033,  France

      Service de Réanimation Médicale - Hôpital Bretonneau, Tours,  37000,  France

Study chairs or principal investigators

Christophe Camus, MD,  Principal Investigator,  Rennes University Hospital   
Eric Bellissant, MD, PhD,  Study Chair,  Rennes University Hospital   

More Information

Publications

Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51.

Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50.

Study ID Numbers:  AFSSAPS 020551; PHRC/01-07; CIC0203/010
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00151606
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13

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