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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)

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. ]
  Show Outcome Measure 1

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. ]
  Show Outcome Measure 2

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. ]
  Show Outcome Measure 3

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:

Other Publications:


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