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
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: 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 July 22, 2014