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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus
• Intervention / Treatment: Drug: Arm 1. Routine Care (Mupirocin/CHG); Drug: Arm 2. Iodophor/CHG Decolonization

• Study Type: Interventional
• Enrollment (Actual): 353323
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92501
      • Riverside Community Hospital
    • San Jose, California, United States, 95124
      • Good Samaritan Hospital
    • San Jose, California, United States, 95116
      • Regional Medical Center of San Jose
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
    • West Hills, California, United States, 91307
      • West Hills Hospital & Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
    • Denver, Colorado, United States, 80220
      • Rose Medical Center
    • Denver, Colorado, United States, 80113
      • Swedish Medical Center
    • Denver, Colorado, United States, 80124
      • Sky Ridge Medical Center
    • Denver, Colorado, United States, 80218
      • Presbyterian St. Luke's Medical Center
    • Thornton, Colorado, United States, 80229
      • North Suburban Medical Center - JV
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Aventura, Florida, United States, 33180
      • Aventura Hospital
    • Bradenton, Florida, United States, 34209
      • Blake Medical Center
    • Brandon, Florida, United States, 33511
      • Brandon Regional
    • Brooksville, Florida, United States, 34613
      • Oak Hill Hospital
    • Englewood, Florida, United States, 34223
      • Englewood Community Hospital
    • Fort Pierce, Florida, United States, 34950
      • Lawnwood Regional Medical Center
    • Fort Walton Beach, Florida, United States, 32547
      • Fort Walton Medical Center
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Hudson, Florida, United States, 34667
      • Regional Medical Center Bayonet Point
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Kissimmee, Florida, United States, 34741
      • Osceola Regional Medical Center
    • Kissimmee, Florida, United States, 34758
      • Poinciana Medical Center
    • Lake City, Florida, United States, 32055
      • Lake City Medical Center
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Loxahatchee Groves, Florida, United States, 33470
      • Palms West Hospital
    • Margate, Florida, United States, 33063
      • Northwest Medical Center
    • Miami, Florida, United States, 33133
      • Mercy Hospital
    • Miami, Florida, United States, 33175
      • Kendall Regional Medical Center
    • Niceville, Florida, United States, 32578
      • Twin Cities Hospital
    • Ocala, Florida, United States, 34471
      • Ocala Regional Medical Center
    • Ocala, Florida, United States, 34474
      • West Marion Community Hospital
    • Okeechobee, Florida, United States, 34972
      • Raulerson Hospital
    • Orange Park, Florida, United States, 32073
      • Orange Park Medical Center
    • Panama City, Florida, United States, 32405
      • Gulf Coast Medical Center
    • Pensacola, Florida, United States, 32514
      • West Florida Hospital
    • Plantation, Florida, United States, 33324
      • Westside Regional Medical Center
    • Plantation, Florida, United States, 33317
      • Plantation General Hospital
    • Port Charlotte, Florida, United States, 33952
      • Fawcett Memorial Hospital
    • Port Saint Lucie, Florida, United States, 34952
      • St. Lucie Medical Center
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Saint Petersburg, Florida, United States, 33710
      • St. Petersburg General Hospital
    • Sanford, Florida, United States, 32771
      • Central Florida Regional Hospital
    • Sarasota, Florida, United States, 34233
      • Doctor's Hospital Sarasota
    • Sun City Center, Florida, United States, 33573
      • South Bay Hospital
    • Tallahassee, Florida, United States, 32308
      • Capital Regional Medical Center
    • Tamarac, Florida, United States, 33321
      • University Hospital & Medical Center
    • Trinity, Florida, United States, 34655
      • Medical Center of Trinity
    • West Palm Beach, Florida, United States, 33407
      • JFK Medical Center - North Campus
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Doctor's Hospital Augusta
    • Cartersville, Georgia, United States, 30120
      • Cartersville Medical Center
    • Dublin, Georgia, United States, 31021
      • Fairview Park
    • Macon, Georgia, United States, 31217
      • Coliseum Medical Centers - Main
    • Macon, Georgia, United States, 31217
      • Coliseum Medical Centers - Northside
    • Rome, Georgia, United States, 30165
      • Redmond Regional Medical Center
    • Snellville, Georgia, United States, 30078
      • Eastside Medical Center
  • Idaho
    • Caldwell, Idaho, United States, 83605
      • West Valley Medical Center
    • Idaho Falls, Idaho, United States, 83404
      • Eastern Idaho Regional
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Terre Haute Regional Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
    • Wichita, Kansas, United States, 67220
      • Wesley Woodlawn Hospital
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Greenview Regional Hospital
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Rapides Regional Medical Center
    • Covington, Louisiana, United States, 70433
      • Lakeview Regional Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital & Clinic
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Garden Park Medical Center
  • Missouri
    • Belton, Missouri, United States, 64012
      • Belton Regional Medical Center
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Lee's Summit, Missouri, United States, 64063
      • Lee's Summit Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Mountainview Hospital - Vegas
    • Las Vegas, Nevada, United States, 89148
      • Southern Hills Hospital - Vegas
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital & Medical Center
  • New Hampshire
    • Derry, New Hampshire, United States, 03038
      • Parkland Medical Center
    • Portsmouth, New Hampshire, United States, 03801
      • Portsmouth Regional Hospital
  • Pennsylvania
    • Fredericksburg, Pennsylvania, United States, 22408
      • Spotsylvania Regional Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Regional Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Regional Medical Center
    • Summerville, South Carolina, United States, 29485
      • Summerville Medical Center
    • Walterboro, South Carolina, United States, 29488
      • Colleton Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Parkridge Medical Center
    • Chattanooga, Tennessee, United States, 37412
      • Parkridge East Hospital
    • Hendersonville, Tennessee, United States, 37075
      • Hendersonville Medical Center
    • Hermitage, Tennessee, United States, 37076
      • Summit Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Nashville, Tennessee, United States, 37211
      • Southern Hills Medical Center
    • Nashville, Tennessee, United States, 37167
      • Stonecrest Medical Center
    • Nashville, Tennessee, United States, 37207
      • Skyline Medical Center
  • Texas
    • Arlington, Texas, United States, 76015
      • Medical Center of Arlington
    • Austin, Texas, United States, 78758
      • North Austin Medical Center
    • Austin, Texas, United States, 78704
      • South Austin Hospital
    • Brownsville, Texas, United States, 78526
      • Valley Regional Medical Center
    • Conroe, Texas, United States, 77304
      • Conroe Regional Medical Center
    • Corpus Christi, Texas, United States, 78411
      • Corpus Christi Medical Center - Doctor's
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Medical Center - The Heart Hospital
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Denton, Texas, United States, 76210
      • Denton Regional Medical Center
    • El Paso, Texas, United States, 79902
      • Las Palmas Medical Center
    • El Paso, Texas, United States, 79925
      • Del Sol Medical Center
    • Fort Worth, Texas, United States, 76104
      • Plaza Medical Center of Fort Worth
    • Houston, Texas, United States, 77082
      • West Houston Medical Center
    • Houston, Texas, United States, 77015
      • East Houston Regional Medical Center
    • Irving, Texas, United States, 75039
      • Las Colinas Medical Center
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
    • Lewisville, Texas, United States, 75057
      • Medical Center of Lewisville
    • McAllen, Texas, United States, 78503
      • Rio Grande Regional Hospital
    • McKinney, Texas, United States, 75069
      • Medical Center of McKinney
    • North Richland Hills, Texas, United States, 76180
      • North Hills Hospital
    • Pasadena, Texas, United States, 77504
      • Bayshore Medical Center
    • Plano, Texas, United States, 75075
      • Medical Center of Plano
    • Round Rock, Texas, United States, 78681
      • Round Rock Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Specialty & Transplant Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Stone Oak Hospital
    • San Antonio, Texas, United States, 78229
      • Northeast Methodist Hospital
    • San Antonio, Texas, United States, 78212
      • Metropolitan Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Texsan Hospital
    • Texas City, Texas, United States, 77591
      • Mainland Medical Center
    • Webster, Texas, United States, 77598
      • Clearlake Regional Medical Center
  • Utah
    • Bountiful, Utah, United States, 84010
      • Lakeview Hospital
    • Ogden, Utah, United States, 84405
      • Ogden Regional Medical Center
    • Orem, Utah, United States, 84057
      • Timpanogos Regional Medical Center
    • Payson, Utah, United States, 84651
      • Mountain View Hospital - Utah
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • LewisGale Hospital - Montgomery
    • Hopewell, Virginia, United States, 23860
      • John Randolph Medical Center
    • Low Moor, Virginia, United States, 24457
      • LewisGale Hospital - Alleghany
    • Pulaski, Virginia, United States, 24301
      • LewisGale Hospital - Pulaski
    • Reston, Virginia, United States, 20190
      • Reston Hospital
    • Richmond, Virginia, United States, 23225
      • CJW Medical Center (Chippenham Campus)
    • Richmond, Virginia, United States, 23225
      • CJW Medical Center (Johnston Willis Campus)
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors' Hospital - Forest Campus
    • Richmond, Virginia, United States, 23294
      • Henrico Doctors' Hospital - Parham Campus
    • Richmond, Virginia, United States, 23220
      • Henrico Doctors' Hospital - Retreat Campus
    • Salem, Virginia, United States, 24153
      • LewisGale Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;
• 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.

Exclusion Criteria:

• Exclusion criteria includes ICUs with an average length of stay of less than 2 days;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Routine Care (Mupirocin/CHG); ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing	Drug: Arm 1. Routine Care (Mupirocin/CHG); 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.
Active Comparator: Arm 2: Iodophor/CHG Decolonization; ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing	Drug: Arm 2. Iodophor/CHG Decolonization; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With ICU Attributable MRSA Clinical Cultures	Methicillin-resistant Staphylococcus aureus (MRSA) 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
Number of Participants With ICU-attributable Bloodstream Infections	All-cause bloodstream infection attributable to participating ICUs. Defined as occurring >2 days into a participating ICU stay through 2 days following ICU discharge.Includes subsets of gram positive (GP), gram negative (GN) and fungal (candida) bloodstream infections, as well as key pathogens such as S. aureus (MRSA and MSSA). NOTE: this outcome is intended for the primary manuscript.	18-month intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mupirocin & Iodophor Resistance in MRSA Isolates	Mupirocin and iodophor resistance as measured by minimum inhibitory concentration (MIC) among MRSA isolates from ICU patients between arms. NOTE: this outcome is intended for a secondary manuscript.	18-month intervention

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Centers for Disease Control and Prevention; University of California, Irvine; University of Massachusetts, Amherst; Rush University; Hospital Corporation of America
• Investigators: Study Director: Susan Huang, MD, MPH, University of California, Irvine; Principal Investigator: Richard Platt, MD, MS, Harvard Pilgrim Health Care Institute

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): November 6, 2023

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: MRSA; mupirocin; resistance; healthcare-associated infections; iodophor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin
• Other Study ID Numbers: PH000599A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No