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)
NCT ID: NCT00980980
Last Updated: 2017-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
74256 participants
INTERVENTIONAL
2009-09-30
2011-09-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PREVENTION
Study Groups
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Arm 1: Usual Care-Active Surveillance
Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
No interventions assigned to this group
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 daily 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, Continuation of 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)
Interventions
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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)
Eligibility Criteria
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Exclusion Criteria
* 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.
13 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Centers for Disease Control and Prevention
FED
Hospital Corporation of America
INDUSTRY
University of California, Irvine
OTHER
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
UNKNOWN
Harvard Pilgrim Health Care
OTHER
Responsible Party
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Richard Platt
Professor and Department Chair
Principal Investigators
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Richard Platt, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Department of Population Medicine, Harvard Medical School / Harvard Pilgrim Healthcare Institute
Edward Septimus, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Corporation of America
Susan Huang, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Locations
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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
Countries
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References
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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.
Huang 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.
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.
Related Links
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NEJM Study Results Publication
Other Identifiers
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HHSA2902005003I
Identifier Type: -
Identifier Source: secondary_id
TO #11
Identifier Type: -
Identifier Source: secondary_id
PH000223K
Identifier Type: -
Identifier Source: org_study_id
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