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: August 18, 2014
Last verified: August 2014
  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.

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: Prevention
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: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. ] [ Designated as safety issue: No ]
    Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.


Secondary Outcome Measures:
  • MRSA Bloodstream Infection [ Time Frame: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. ] [ Designated as safety issue: No ]
    Hazard ratio for ICU-attributable MRSA+ blood cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.

  • ICU-attributable All-pathogen Bloodstream Infection [ Time Frame: The 30-month time frame represents 12-month baseline and 18-month intervention periods. During these time periods, outcomes are defined as events occurring during attributed ICU time: from day 3 of the ICU stay until 2 days after ICU discharge. ] [ Designated as safety issue: No ]
    Hazard ratio for ICU-attributable positive blood culture from any pathogen, comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.

  • 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: 74256
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 , plus 5 days of 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, Continuation of 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 , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)

Detailed Description:

Baseline data involving 12 months of data for participating hospitals (July 2008 - June 2009) was collected prior to randomization to account for size and ICU baseline prevalence of MRSA in randomization scheme. Randomization occurred at the hospital level.

Eligibility survey was conducted to determine exclusion criteria.

As of May 2010, enrollment has been closed. 45 hospitals were randomized, but two were found to meet exclusion criteria and were excluded. As-randomized (or as-assigned) analysis included 43 hospitals, representing 74 ICUs. Individual (patient-level) subject enrollment during intervention is 74,256.

  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

  Hide Study Locations
Locations
United States, Alaska
Alaska Regional
Anchorage, Alaska, United States
United States, California
Los Robles Hosp & Med Ctr
Thousand Oaks, California, United States
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States
United States, Florida
Blake Medical Center
Brandenton, Florida, United States
Brandon Hospital
Brandon, Florida, United States
Plantation General
Ft. Lauderdale, Florida, United States
Columbia Hosp Corp S Broward (Westside)
Ft. Lauderdale, Florida, United States
Palms West Hospital
Ft. Lauderdale, Florida, United States
Regional Med Cr Bayonet Point
Hudson, Florida, United States
Largo Medical Center
Largo, Florida, United States
Community Hospital
New Port Richey, Florida, United States
Orange Park Med Ctr
Orange Park, Florida, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, United States
Doctors Hospital of Sarasota
Sarasota, Florida, United States
South Bay Hospital
Sun City Center, Florida, United States
Capital Regional Med Ctr
Tallahassee, Florida, United States
United States, Georgia
Coliseum Medical Center
Macon, Georgia, United States
Coliseum (Macon) Northside
Macon, Georgia, United States
Cartersville Medical Center
Tucker, Georgia, United States
United States, Idaho
Eastern Idaho Reg Med Ctr
Idaho Falls, Idaho, United States
United States, Mississippi
Garden Park Medical Center
Gulfport, Mississippi, United States
United States, Missouri
Overland Park Regional Hospital
Kansas City, Missouri, United States
Research Belton Hospital
Kansas City, Missouri, United States
Lee's Summit Medical Center
Kansas City, Missouri, United States
Menorah Medical Center
Kansas City, Missouri, United States
United States, Nevada
Moutainview Medical Center
Las Vegas, Nevada, United States
United States, New Hampshire
Parkland Medical Center
Derry, New Hampshire, United States
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
United States, South Carolina
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
United States, Tennessee
Parkridge Medical Center
Chattanooga, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Stonecrest
Smyrna, Tennessee, United States
United States, Texas
St. David's Medical Center
Austin, Texas, United States
Del Sol Medical Center
El Paso, Texas, United States
Las Palmas Medical Center
El Paso, Texas, United States
Medical Center of Plano
Plano, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Clear Lake Regional
Webster, Texas, United States
United States, Virginia
Montgomery Regional Hospital
Blacksburg, Virginia, United States
Columbia Alleghany Regional Hospital
LowMoor, Virginia, United States
Pulaski Community Hospital
Pulaski, Virginia, United States
Chippenham Johnston Willis
Richmond, Virginia, United States
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
Results First Received: May 14, 2014
Last Updated: August 18, 2014
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
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014