Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs) (REDUCE - MRSA)

This study has been completed.
Sponsor:
Collaborators:
Hospital Corporation of America
University of California, Irvine
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT00980980
First received: September 19, 2009
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant Staphylococcus aureus (MRSA) in intensive care units. The three strategies to be evaluated are:

  • screening on admission followed by isolation of MRSA+ patients
  • screening on admission followed by isolation and decolonization of MRSA+ patients
  • universal decolonization on admission with no screening. The decolonization regimen involves bathing with chlorhexidine plus intra-nasal application of mupirocin. The main outcome will be MRSA+ clinical cultures.

    • Note that enrolled "subjects" represents 42 individual HCA Hospitals (representing ~70 ICUs) have been randomized. The study is a partnership between the CDC, the CDC Prevention Epicenters, and the Hospital Corporation of America.

Condition Intervention
Methicillin-resistant Staphylococcus Aureus
Drug: Chlorhexidine bath and nasal mupirocin

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Health Services Research
Official Title: Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal

Resource links provided by NLM:


Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Main Outcome: Patients with Nosocomial MRSA Clinical Cultures [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRSA Bloodstream Infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • ICU-attributable All-pathogen Bloodstream Infection [ Time Frame: 18-months ] [ Designated as safety issue: No ]
    Note:CLABSI outcome was dropped due to an inability to acquire standardized denominators for this measure.

  • Urinary tract infections [ Time Frame: 18-months ] [ Designated as safety issue: No ]
  • Emergence of resistance to mupirocin and chlorhexidine [ Time Frame: 18-months ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: 18-months ] [ Designated as safety issue: No ]
  • Blood culture contamination [ Time Frame: 18-months ] [ Designated as safety issue: No ]

Enrollment: 71609
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1: Usual Care-Active Surveillance
Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
Active Comparator: Arm 2: Targeted Decolonization
Continue Active Surveillance (AS) MRSA decolonization based on AS Continue Contact Precautions for MRSA+
Drug: Chlorhexidine bath and nasal mupirocin
The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths applied to intact skin plus topical intranasal mupirocin ointment (bilateral nares, twice daily)
Active Comparator: Arm 3: Universal Decolonization
Chlorhexidine bath and nasal mupirocin for all Discontinuation of Active Surveillance Contact Precautions for MRSA+
Drug: Chlorhexidine bath and nasal mupirocin
The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths applied to intact skin plus topical intranasal mupirocin ointment (bilateral nares, twice daily)

Detailed Description:

As of May,2010, enrollment has been closed. As-treated analysis includes 42 hospitals, representing 72 ICUs. Individual (patient-level) subject enrollment is 71,609.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria will include all HCA hospitals that reside in US states where physicians do NOT routinely prescribe decolonization for MRSA + ICU patients.

Exclusion Criteria:

  • Exclusion criteria will include hospitals where ICU physicians often prescribe decolonization for MRSA+ ICU patients.
  • Dedicated burn ICUs will also be excluded due to the inability to perform routine bathing.
  • Finally, since the intent is to assess the intervention in adult ICUs, pediatric hospitals will be excluded although patients <13 years old that are admitted to participating adult ICUs will be included in the unit-based intervention.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980980

  Show 42 Study Locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
Hospital Corporation of America
University of California, Irvine
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Investigators
Principal Investigator: Richard Platt, MD, MS Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Principal Investigator: Edward Septimus, MD Hospital Corporation of America (HCA)
Principal Investigator: Susan Huang, MD MPH University of California, Irvine
  More Information

Additional Information:
Publications:
Responsible Party: Richard Platt, Professor and Department Chair, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT00980980     History of Changes
Other Study ID Numbers: PH000223K, HHSA2902005003I, TO #11
Study First Received: September 19, 2009
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
MRSA infection

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 15, 2014