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) - Full Text View

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.

First Received on September 19, 2009. Last Updated on October 24, 2011 History of Changes

Sponsor:	Harvard Pilgrim Health Care
Collaborators:	Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention Hospital Corporation of America University of California, Irvine Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Information provided by:	Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:	NCT00980980

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:

Drug Information available for: Chlorhexidine Mupirocin Chlorhexidine digluconate Hibiclens Mupirocin calcium

U.S. FDA Resources

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:

Nosocomial MRSA Bloodstream and Urinary Cultures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Routinely reported central line associated blood stream infections (CLABSI). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	58975
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 at 42 hospitals, representing ~70 ICUs. Individual (patient-level) subject enrollment is TBD.

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

Agency for Healthcare Research and Quality (AHRQ)

Centers for Disease Control and Prevention

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

Publications:

Platt R, Takvorian SU, Septimus E, Hickok J, Moody J, Perlin J, Jernigan JA, Kleinman K, Huang SS. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections. Med Care. 2010 Jun;48(6 Suppl):S52-7.

Responsible Party:	Richard Platt, MD MS, Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
ClinicalTrials.gov Identifier:	NCT00980980 History of Changes
Other Study ID Numbers:	PH000223K, HHSA2902005003I, TO #11
Study First Received:	September 19, 2009
Last Updated:	October 24, 2011
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 February 09, 2012