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
3 other identifiers
interventional
74,256
1 country
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Typical duration for not_applicable
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 19, 2009
CompletedFirst Posted
Study publicly available on registry
September 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
July 30, 2014
CompletedMay 2, 2017
March 1, 2017
2 years
September 19, 2009
May 14, 2014
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Main Outcome: Patients With Nosocomial MRSA Clinical Cultures
Hazard ratio for ICU-attributable MRSA+ clinical cultures comparing Baseline to Intervention period, by Arm, accounting for clustering by hospital.
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.
Secondary Outcomes (7)
MRSA Bloodstream Infection
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.
ICU-attributable All-pathogen Bloodstream Infection
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.
Intervention Impact on Healthcare Costs
12-month period
Blood Culture Contamination Rates
24-month time frame for this analysis represents a 6-month baseline and 18-month intervention period.
Intervention Impact on Bacteriuria and Candiduria
30-month time frame represents 12-month baseline and 18-month intervention periods.
- +2 more secondary outcomes
Study Arms (3)
Arm 1: Usual Care-Active Surveillance
NO INTERVENTIONActive Surveillance in All Adult ICUs, Contact Precautions for MRSA+
Arm 2: Targeted Decolonization
ACTIVE COMPARATORContinue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+
Arm 3: Universal Decolonization
ACTIVE COMPARATORChlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+
Interventions
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)
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard Pilgrim Health Carelead
- Agency for Healthcare Research and Quality (AHRQ)collaborator
- Centers for Disease Control and Preventioncollaborator
- Hospital Corporation of Americacollaborator
- University of California, Irvinecollaborator
- Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institutecollaborator
Study Sites (42)
Alaska Regional
Anchorage, Alaska, United States
Los Robles Hosp & Med Ctr
Thousand Oaks, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Blake Medical Center
Brandenton, Florida, United States
Brandon Hospital
Brandon, Florida, United States
Columbia Hosp Corp S Broward (Westside)
Fort Lauderdale, Florida, United States
Palms West Hospital
Fort Lauderdale, Florida, United States
Plantation General
Fort 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
Coliseum (Macon) Northside
Macon, Georgia, United States
Coliseum Medical Center
Macon, Georgia, United States
Cartersville Medical Center
Tucker, Georgia, United States
Eastern Idaho Reg Med Ctr
Idaho Falls, Idaho, United States
Garden Park Medical Center
Gulfport, Mississippi, United States
Lee's Summit Medical Center
Kansas City, Missouri, United States
Menorah Medical Center
Kansas City, Missouri, United States
Overland Park Regional Hospital
Kansas City, Missouri, United States
Research Belton Hospital
Kansas City, Missouri, United States
Moutainview Medical Center
Las Vegas, Nevada, United States
Parkland Medical Center
Derry, New Hampshire, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
Parkridge Medical Center
Chattanooga, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Stonecrest
Smyrna, Tennessee, United States
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
Montgomery Regional Hospital
Blacksburg, Virginia, United States
Columbia Alleghany Regional Hospital
Low Moor, Virginia, United States
Pulaski Community Hospital
Pulaski, Virginia, United States
Chippenham Johnston Willis
Richmond, Virginia, United States
Related Publications (3)
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.
PMID: 20473200BACKGROUNDHuang SS, Septimus E, Platt R. Targeted decolonization to prevent ICU infections. N Engl J Med. 2013 Oct 10;369(15):1470-1. doi: 10.1056/NEJMc1309704. No abstract available.
PMID: 24106942BACKGROUNDHuang 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.
PMID: 23718152RESULT
Related Links
Results Point of Contact
- Title
- Dr. Susan Huang
- Organization
- University of California, Irvine
Study Officials
- 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
- PRINCIPAL INVESTIGATOR
Susan Huang, MD MPH
University of California, Irvine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Department Chair
Study Record Dates
First Submitted
September 19, 2009
First Posted
September 21, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
May 2, 2017
Results First Posted
July 30, 2014
Record last verified: 2017-03