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Staphylococcus AureusPhase 4NCT03140423

Mupirocin-Iodophor ICU Decolonization Swap Out Trial

A Phase 4 study testing Arm 1. Routine Care (Mupirocin/CHG) and Arm 2. Iodophor/CHG Decolonization in people with Staphylococcus Aureus, run by Harvard Pilgrim Health Care at 137 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Staphylococcus Aureus
What is being tested?
Arm 1. Routine Care (Mupirocin/CHG) and Arm 2. Iodophor/CHG Decolonization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
353,323 participants
Where
137 sitesUnited States
Study dates
1 May 2017to 6 Nov 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

137 sites in 1 country.

137 sites in 1 country

United States137 sites
  • Rapides Regional Medical Center

    Alexandria, Louisiana, 71301

  • Medical Center of Arlington

    Arlington, Texas, 76015

  • JFK Medical Center

    Atlantis, Florida, 33462

  • Doctor's Hospital Augusta

    Augusta, Georgia, 30909

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • South Austin Hospital

    Austin, Texas, 78704

  • North Austin Medical Center

    Austin, Texas, 78758

  • Aventura Hospital

    Aventura, Florida, 33180

  • Belton Regional Medical Center

    Belton, Missouri, 64012

  • LewisGale Hospital - Montgomery

    Blacksburg, Virginia, 24060

  • Lakeview Hospital

    Bountiful, Utah, 84010

  • Greenview Regional Hospital

    Bowling Green, Kentucky, 42104

  • Blake Medical Center

    Bradenton, Florida, 34209

  • Brandon Regional

    Brandon, Florida, 33511

  • Oak Hill Hospital

    Brooksville, Florida, 34613

  • Valley Regional Medical Center

    Brownsville, Texas, 78526

  • West Valley Medical Center

    Caldwell, Idaho, 83605

  • Cartersville Medical Center

    Cartersville, Georgia, 30120

  • Trident Regional Medical Center

    Charleston, South Carolina, 29406

  • Parkridge Medical Center

    Chattanooga, Tennessee, 37404

  • Parkridge East Hospital

    Chattanooga, Tennessee, 37412

  • Conroe Regional Medical Center

    Conroe, Texas, 77304

  • Corpus Christi Medical Center - Doctor's

    Corpus Christi, Texas, 78411

  • Corpus Christi Medical Center - The Heart Hospital

    Corpus Christi, Texas, 78412

  • Lakeview Regional Medical Center

    Covington, Louisiana, 70433

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Denton Regional Medical Center

    Denton, Texas, 76210

  • Swedish Medical Center

    Denver, Colorado, 80113

  • Sky Ridge Medical Center

    Denver, Colorado, 80124

  • Presbyterian St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Parkland Medical Center

    Derry, New Hampshire, 03038

  • Fairview Park

    Dublin, Georgia, 31021

  • Las Palmas Medical Center

    El Paso, Texas, 79902

  • Del Sol Medical Center

    El Paso, Texas, 79925

  • Englewood Community Hospital

    Englewood, Florida, 34223

  • Fort Walton Medical Center

    Fort Walton Beach, Florida, 32547

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Spotsylvania Regional Medical Center

    Fredericksburg, Pennsylvania, 22408

  • Lawnwood Regional Medical Center

    Ft. Pierce, Florida, 34950

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • Garden Park Medical Center

    Gulfport, Mississippi, 39503

  • Hendersonville Medical Center

    Hendersonville, Tennessee, 37075

  • Summit Medical Center

    Hermitage, Tennessee, 37076

  • John Randolph Medical Center

    Hopewell, Virginia, 23860

  • East Houston Regional Medical Center

    Houston, Texas, 77015

  • West Houston Medical Center

    Houston, Texas, 77082

  • Regional Medical Center Bayonet Point

    Hudson, Florida, 34667

  • Eastern Idaho Regional

    Idaho Falls, Idaho, 83404

  • Centerpoint Medical Center

    Independence, Missouri, 64057

  • Las Colinas Medical Center

    Irving, Texas, 75039

  • Memorial Hospital Jacksonville

    Jacksonville, Florida, 32216

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kingwood Medical Center

    Kingwood, Texas, 77339

  • Osceola Regional Medical Center

    Kissimmee, Florida, 34741

  • Poinciana Medical Center

    Kissimmee, Florida, 34758

  • Lake City Medical Center

    Lake City, Florida, 32055

  • Largo Medical Center

    Largo, Florida, 33770

  • Sunrise Hospital & Medical Center

    Las Vegas, Nevada, 89109

  • Mountainview Hospital - Vegas

    Las Vegas, Nevada, 89128

  • Southern Hills Hospital - Vegas

    Las Vegas, Nevada, 89148

  • Lee's Summit Medical Center

    Lee's Summit, Missouri, 64063

  • Medical Center of Lewisville

    Lewisville, Texas, 75057

  • LewisGale Hospital - Alleghany

    Low Moor, Virginia, 24457

  • Palms West Hospital

    Loxahatchee Groves, Florida, 33470

  • Coliseum Medical Centers - Main

    Macon, Georgia, 31217

  • Coliseum Medical Centers - Northside

    Macon, Georgia, 31217

  • Northwest Medical Center

    Margate, Florida, 33063

  • Rio Grande Regional Hospital

    McAllen, Texas, 78503

  • Medical Center of McKinney

    McKinney, Texas, 75069

  • Mercy Hospital

    Miami, Florida, 33133

  • Kendall Regional Medical Center

    Miami, Florida, 33175

  • Grand Strand Regional Medical Center

    Myrtle Beach, South Carolina, 29572

  • Stonecrest Medical Center

    Nashville, Tennessee, 37167

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Skyline Medical Center

    Nashville, Tennessee, 37207

  • Southern Hills Medical Center

    Nashville, Tennessee, 37211

  • Tulane University Hospital & Clinic

    New Orleans, Louisiana, 70112

  • Twin Cities Hospital

    Niceville, Florida, 32578

  • North Hills Hospital

    North Richland Hills, Texas, 76180

  • Ocala Regional Medical Center

    Ocala, Florida, 34471

  • West Marion Community Hospital

    Ocala, Florida, 34474

  • Ogden Regional Medical Center

    Ogden, Utah, 84405

  • Raulerson Hospital

    Okeechobee, Florida, 34972

  • Orange Park Medical Center

    Orange Park, Florida, 32073

  • Timpanogos Regional Medical Center

    Orem, Utah, 84057

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215

  • Gulf Coast Medical Center

    Panama City, Florida, 32405

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • Mountain View Hospital - Utah

    Payson, Utah, 84651

  • West Florida Hospital

    Pensacola, Florida, 32514

  • Medical Center of Plano

    Plano, Texas, 75075

  • Plantation General Hospital

    Plantation, Florida, 33317

  • Westside Regional Medical Center

    Plantation, Florida, 33324

  • Fawcett Memorial Hospital

    Port Charlotte, Florida, 33952

  • St. Lucie Medical Center

    Port Saint Lucie, Florida, 34952

  • Portsmouth Regional Hospital

    Portsmouth, New Hampshire, 03801

  • LewisGale Hospital - Pulaski

    Pulaski, Virginia, 24301

  • Reston Hospital

    Reston, Virginia, 20190

  • Henrico Doctors' Hospital - Retreat Campus

    Richmond, Virginia, 23220

  • CJW Medical Center (Chippenham Campus)

    Richmond, Virginia, 23225

  • CJW Medical Center (Johnston Willis Campus)

    Richmond, Virginia, 23225

  • Henrico Doctors' Hospital - Forest Campus

    Richmond, Virginia, 23229

  • Henrico Doctors' Hospital - Parham Campus

    Richmond, Virginia, 23294

  • Riverside Community Hospital

    Riverside, California, 92501

  • Redmond Regional Medical Center

    Rome, Georgia, 30165

  • Round Rock Hospital

    Round Rock, Texas, 78681

  • LewisGale Medical Center

    Salem, Virginia, 24153

  • Metropolitan Methodist Hospital

    San Antonio, Texas, 78212

  • Methodist Hospital

    San Antonio, Texas, 78229

  • Methodist Specialty & Transplant Hospital

    San Antonio, Texas, 78229

  • Methodist Stone Oak Hospital

    San Antonio, Texas, 78229

  • Methodist Texsan Hospital

    San Antonio, Texas, 78229

  • Northeast Methodist Hospital

    San Antonio, Texas, 78229

  • Regional Medical Center of San Jose

    San Jose, California, 95116

  • Good Samaritan Hospital

    San Jose, California, 95124

  • Central Florida Regional Hospital

    Sanford, Florida, 32771

  • Doctor's Hospital Sarasota

    Sarasota, Florida, 34233

  • Eastside Medical Center

    Snellville, Georgia, 30078

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • St. Petersburg General Hospital

    St. Petersburg, Florida, 33710

  • Summerville Medical Center

    Summerville, South Carolina, 29485

  • South Bay Hospital

    Sun City Center, Florida, 33573

  • Capital Regional Medical Center

    Tallahassee, Florida, 32308

  • University Hospital & Medical Center

    Tamarac, Florida, 33321

  • Terre Haute Regional Hospital

    Terre Haute, Indiana, 47802

  • Mainland Medical Center

    Texas City, Texas, 77591

  • North Suburban Medical Center - JV

    Thornton, Colorado, 80229

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • Medical Center of Trinity

    Trinity, Florida, 34655

  • Colleton Medical Center

    Walterboro, South Carolina, 29488

  • Clearlake Regional Medical Center

    Webster, Texas, 77598

  • West Hills Hospital & Medical Center

    West Hills, California, 91307

  • JFK Medical Center - North Campus

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Wesley Woodlawn Hospital

    Wichita, Kansas, 67220

Other trials in United States

About this study

Official title: 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.

Being tested
Arm 1. Routine Care (Mupirocin/CHG), Arm 2. Iodophor/CHG Decolonization
Keywords
MRSA, healthcare-associated infections, mupirocin, iodophor, resistance
Medical subject headings
Staphylococcal Infections, Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 1. Routine Care (Mupirocin/CHG)Drug

    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.

  • Arm 2. Iodophor/CHG DecolonizationDrug

    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.

Study groups in NCT03140423
Study groupRoleWhat they receive
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
Receives: Drug: Arm 1. Routine Care (Mupirocin/CHG)
Arm 2: Iodophor/CHG DecolonizationActive comparatorICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
Receives: Drug: Arm 2. Iodophor/CHG Decolonization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 18-month intervention

Secondary outcomes (2)
  1. 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.

    Measured: 18-month intervention

  2. 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.

    Measured: 18-month intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start1 May 2017
  3. Primary completion6 Nov 2023
  4. Study completion6 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Non-inferiority cluster randomized controlled trial
Masking
None (open label)
Enrolment
353,323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03140423
Sponsor's protocol ID
PH000599A
Status last verified
Mar 2025
First submitted
12 Apr 2017
Last updated
30 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37815567

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Arm 1. Routine Care (Mupirocin/CHG) and Arm 2. Iodophor/CHG Decolonization in people with Staphylococcus Aureus, run by Harvard Pilgrim Health Care at 137 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures (time frame: 18-month intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03140423, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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