Mupirocin-Iodophor ICU Decolonization Swap Out Trial
Cluster-randomized Non-inferiority Trial Comparing Mupirocin vs Iodophor for Nasal Decolonization of ICU Patients to Assess Impact on S. Aureus Clinical Cultures and All-cause Bloodstream Infection During Routine Chlorhexidine Bathing
1 other identifier
interventional
353,323
1 country
137
Brief Summary
The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens: Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing \~235 ICUs) that have been randomized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2017
Longer than P75 for phase_4
137 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2023
CompletedResults Posted
Study results publicly available
February 7, 2024
CompletedMarch 30, 2025
March 1, 2025
6.5 years
April 12, 2017
November 6, 2023
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
18-month intervention
Secondary Outcomes (2)
Number of Participants With ICU Attributable MRSA Clinical Cultures
18-month intervention
Number of Participants With ICU-attributable Bloodstream Infections
18-month intervention
Study Arms (2)
Arm 1: Routine Care (Mupirocin/CHG)
ACTIVE COMPARATORICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
Arm 2: Iodophor/CHG Decolonization
ACTIVE COMPARATORICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Interventions
The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
Eligibility Criteria
You may qualify if:
- Note: Unit of randomization is the hospital, but the participants are hospital adult ICUs
- All patients within adult ICUs are included, including rare patients \<18 years and \>=12 years.
You may not qualify if:
- HCA hospitals that are not able to transfer or merge data into the centralized data warehouse for the baseline and intervention periods of the study are also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard Pilgrim Health Carelead
- Hospital Corporation of Americacollaborator
- University of California, Irvinecollaborator
- University of Massachusetts, Amherstcollaborator
- Rush Universitycollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (137)
Riverside Community Hospital
Riverside, California, 92501, United States
Regional Medical Center of San Jose
San Jose, California, 95116, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
West Hills Hospital & Medical Center
West Hills, California, 91307, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Swedish Medical Center
Denver, Colorado, 80113, United States
Sky Ridge Medical Center
Denver, Colorado, 80124, United States
Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
North Suburban Medical Center - JV
Thornton, Colorado, 80229, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Aventura Hospital
Aventura, Florida, 33180, United States
Blake Medical Center
Bradenton, Florida, 34209, United States
Brandon Regional
Brandon, Florida, 33511, United States
Oak Hill Hospital
Brooksville, Florida, 34613, United States
Englewood Community Hospital
Englewood, Florida, 34223, United States
Fort Walton Medical Center
Fort Walton Beach, Florida, 32547, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Regional Medical Center Bayonet Point
Hudson, Florida, 34667, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Poinciana Medical Center
Kissimmee, Florida, 34758, United States
Lake City Medical Center
Lake City, Florida, 32055, United States
Largo Medical Center
Largo, Florida, 33770, United States
Palms West Hospital
Loxahatchee Groves, Florida, 33470, United States
Northwest Medical Center
Margate, Florida, 33063, United States
Mercy Hospital
Miami, Florida, 33133, United States
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Twin Cities Hospital
Niceville, Florida, 32578, United States
Ocala Regional Medical Center
Ocala, Florida, 34471, United States
West Marion Community Hospital
Ocala, Florida, 34474, United States
Raulerson Hospital
Okeechobee, Florida, 34972, United States
Orange Park Medical Center
Orange Park, Florida, 32073, United States
Gulf Coast Medical Center
Panama City, Florida, 32405, United States
West Florida Hospital
Pensacola, Florida, 32514, United States
Plantation General Hospital
Plantation, Florida, 33317, United States
Westside Regional Medical Center
Plantation, Florida, 33324, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952, United States
Central Florida Regional Hospital
Sanford, Florida, 32771, United States
Doctor's Hospital Sarasota
Sarasota, Florida, 34233, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
St. Petersburg General Hospital
St. Petersburg, Florida, 33710, United States
South Bay Hospital
Sun City Center, Florida, 33573, United States
Capital Regional Medical Center
Tallahassee, Florida, 32308, United States
University Hospital & Medical Center
Tamarac, Florida, 33321, United States
Medical Center of Trinity
Trinity, Florida, 34655, United States
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407, United States
Doctor's Hospital Augusta
Augusta, Georgia, 30909, United States
Cartersville Medical Center
Cartersville, Georgia, 30120, United States
Fairview Park
Dublin, Georgia, 31021, United States
Coliseum Medical Centers - Main
Macon, Georgia, 31217, United States
Coliseum Medical Centers - Northside
Macon, Georgia, 31217, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
Eastside Medical Center
Snellville, Georgia, 30078, United States
West Valley Medical Center
Caldwell, Idaho, 83605, United States
Eastern Idaho Regional
Idaho Falls, Idaho, 83404, United States
Terre Haute Regional Hospital
Terre Haute, Indiana, 47802, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Wesley Woodlawn Hospital
Wichita, Kansas, 67220, United States
Greenview Regional Hospital
Bowling Green, Kentucky, 42104, United States
Rapides Regional Medical Center
Alexandria, Louisiana, 71301, United States
Lakeview Regional Medical Center
Covington, Louisiana, 70433, United States
Tulane University Hospital & Clinic
New Orleans, Louisiana, 70112, United States
Garden Park Medical Center
Gulfport, Mississippi, 39503, United States
Belton Regional Medical Center
Belton, Missouri, 64012, United States
Centerpoint Medical Center
Independence, Missouri, 64057, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063, United States
Sunrise Hospital & Medical Center
Las Vegas, Nevada, 89109, United States
Mountainview Hospital - Vegas
Las Vegas, Nevada, 89128, United States
Southern Hills Hospital - Vegas
Las Vegas, Nevada, 89148, United States
Parkland Medical Center
Derry, New Hampshire, 03038, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Spotsylvania Regional Medical Center
Fredericksburg, Pennsylvania, 22408, United States
Trident Regional Medical Center
Charleston, South Carolina, 29406, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572, United States
Summerville Medical Center
Summerville, South Carolina, 29485, United States
Colleton Medical Center
Walterboro, South Carolina, 29488, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
Parkridge East Hospital
Chattanooga, Tennessee, 37412, United States
Hendersonville Medical Center
Hendersonville, Tennessee, 37075, United States
Summit Medical Center
Hermitage, Tennessee, 37076, United States
Stonecrest Medical Center
Nashville, Tennessee, 37167, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Skyline Medical Center
Nashville, Tennessee, 37207, United States
Southern Hills Medical Center
Nashville, Tennessee, 37211, United States
Medical Center of Arlington
Arlington, Texas, 76015, United States
South Austin Hospital
Austin, Texas, 78704, United States
North Austin Medical Center
Austin, Texas, 78758, United States
Valley Regional Medical Center
Brownsville, Texas, 78526, United States
Conroe Regional Medical Center
Conroe, Texas, 77304, United States
Corpus Christi Medical Center - Doctor's
Corpus Christi, Texas, 78411, United States
Corpus Christi Medical Center - The Heart Hospital
Corpus Christi, Texas, 78412, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Denton Regional Medical Center
Denton, Texas, 76210, United States
Las Palmas Medical Center
El Paso, Texas, 79902, United States
Del Sol Medical Center
El Paso, Texas, 79925, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104, United States
East Houston Regional Medical Center
Houston, Texas, 77015, United States
West Houston Medical Center
Houston, Texas, 77082, United States
Las Colinas Medical Center
Irving, Texas, 75039, United States
Kingwood Medical Center
Kingwood, Texas, 77339, United States
Medical Center of Lewisville
Lewisville, Texas, 75057, United States
Rio Grande Regional Hospital
McAllen, Texas, 78503, United States
Medical Center of McKinney
McKinney, Texas, 75069, United States
North Hills Hospital
North Richland Hills, Texas, 76180, United States
Bayshore Medical Center
Pasadena, Texas, 77504, United States
Medical Center of Plano
Plano, Texas, 75075, United States
Round Rock Hospital
Round Rock, Texas, 78681, United States
Metropolitan Methodist Hospital
San Antonio, Texas, 78212, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Methodist Specialty & Transplant Hospital
San Antonio, Texas, 78229, United States
Methodist Stone Oak Hospital
San Antonio, Texas, 78229, United States
Methodist Texsan Hospital
San Antonio, Texas, 78229, United States
Northeast Methodist Hospital
San Antonio, Texas, 78229, United States
Mainland Medical Center
Texas City, Texas, 77591, United States
Clearlake Regional Medical Center
Webster, Texas, 77598, United States
Lakeview Hospital
Bountiful, Utah, 84010, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
Timpanogos Regional Medical Center
Orem, Utah, 84057, United States
Mountain View Hospital - Utah
Payson, Utah, 84651, United States
LewisGale Hospital - Montgomery
Blacksburg, Virginia, 24060, United States
John Randolph Medical Center
Hopewell, Virginia, 23860, United States
LewisGale Hospital - Alleghany
Low Moor, Virginia, 24457, United States
LewisGale Hospital - Pulaski
Pulaski, Virginia, 24301, United States
Reston Hospital
Reston, Virginia, 20190, United States
Henrico Doctors' Hospital - Retreat Campus
Richmond, Virginia, 23220, United States
CJW Medical Center (Chippenham Campus)
Richmond, Virginia, 23225, United States
CJW Medical Center (Johnston Willis Campus)
Richmond, Virginia, 23225, United States
Henrico Doctors' Hospital - Forest Campus
Richmond, Virginia, 23229, United States
Henrico Doctors' Hospital - Parham Campus
Richmond, Virginia, 23294, United States
LewisGale Medical Center
Salem, Virginia, 24153, United States
Related Publications (1)
Huang SS, Septimus EJ, Kleinman K, Heim LT, Moody JA, Avery TR, McLean L, Rashid S, Haffenreffer K, Shimelman L, Staub-Juergens W, Spencer-Smith C, Sljivo S, Rosen E, Poland RE, Coady MH, Lee CH, Blanchard EJ, Reddish K, Hayden MK, Weinstein RA, Carver B, Smith K, Hickok J, Lolans K, Khan N, Sturdevant SG, Reddy SC, Jernigan JA, Sands KE, Perlin JB, Platt R. Nasal Iodophor Antiseptic vs Nasal Mupirocin Antibiotic in the Setting of Chlorhexidine Bathing to Prevent Infections in Adult ICUs: A Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1337-1347. doi: 10.1001/jama.2023.17219.
PMID: 37815567RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
\[Not Specified\]
Results Point of Contact
- Title
- Dr. Susan S. Huang, MD, MPH
- Organization
- Division of Infectious Diseases, University of California Irvine School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Platt, MD, MS
Harvard Pilgrim Health Care Institute
- STUDY DIRECTOR
Susan Huang, MD, MPH
University of California, Irvine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Department Chair
Study Record Dates
First Submitted
April 12, 2017
First Posted
May 4, 2017
Study Start
May 1, 2017
Primary Completion
November 6, 2023
Study Completion
November 6, 2023
Last Updated
March 30, 2025
Results First Posted
February 7, 2024
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share