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:

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 (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

History of Changes

Results First Received: May 14, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Primary Purpose: Prevention
Condition:	Methicillin-resistant Staphylococcus Aureus
Intervention:	Drug: Chlorhexidine bath and nasal mupirocin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
45 out of 165 Hospital Corporation of America (HCA) hospitals were recruited for this trial of adult ICUs. There was a 12-month baseline period from January 1 through December 31, 2009; a phase-in period from January 1 through April 7, 2010; and an 18-month intervention period from April 8, 2010 through September 30, 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
74,256 patients were involved in the intervention period among adult ICUs from the 43 participating hospitals. Routinely collected information for about 48,390 individuals cared for during the baseline period was used for comparison to the experience of the patients in all three arms of the Intervention period.

Reporting Groups

	Description
Arm 1: Usual Care-Active Surveillance	Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
Arm 2: Targeted Decolonization	Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+ Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)
Arm 3: Universal Decolonization	Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+ 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)

Description

Arm 1: Usual Care-Active Surveillance

Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+

Arm 2: Targeted Decolonization

Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+

Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)

Arm 3: Universal Decolonization

Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+

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)

Participant Flow: Overall Study

	Arm 1: Usual Care-Active Surveillance	Arm 2: Targeted Decolonization	Arm 3: Universal Decolonization
STARTED	16	14	13
COMPLETED	16	13	13
NOT COMPLETED	0	1	0
Withdrawal by Hospital	0	1	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

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. ]

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2. Secondary:

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. ]

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3. Secondary:

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. ]

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4. Secondary:

Urinary Tract Infections [ Time Frame: 18-months ]

Results not yet reported. Anticipated Reporting Date: 06/2015 Safety Issue: No

5. Secondary:

Emergence of Resistance to Mupirocin and Chlorhexidine [ Time Frame: 18-months ]

Results not yet reported. Anticipated Reporting Date: 03/2015 Safety Issue: No

6. Secondary:

Cost Effectiveness [ Time Frame: 18-months ]

Results not yet reported. Anticipated Reporting Date: 12/2014 Safety Issue: No

7. Secondary:

Blood Culture Contamination [ Time Frame: 18-months ]

Results not yet reported. Anticipated Reporting Date: 12/2014 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Susan Huang
Organization: University of California, Irvine
phone: 949-824-5073
e-mail: sshuang@uci.edu

Publications of Results:

Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29. Erratum in: N Engl J Med. 2013 Aug 8;369(6):587. N Engl J Med. 2014 Feb 27;370(9):886.

Other 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. doi: 10.1097/MLR.0b013e3181dbebcf.

Responsible Party:	Richard Platt, 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

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