Clinical trial NCT03140423: Mupirocin-Iodophor ICU Decolonization Swap Out Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Staphylococcus Aureus
Keywords: MRSA
healthcare-associated infections
mupirocin
iodophor
resistance
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Hospital Corporation of America
name: University of California, Irvine
name: University of Massachusetts, Amherst
name: Rush University
name: Centers for Disease Control and Prevention
First posted: 2017-05-04
Enrollment: 353323
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority cluster randomized controlled trial
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
timeFrame: 18-month intervention
Secondary outcomes:
measure: Number of Participants With ICU Attributable MRSA Clinical Cultures
timeFrame: 18-month intervention
measure: Number of Participants With ICU-attributable Bloodstream Infections
timeFrame: 18-month intervention
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Center of San Jose
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: West Hills
country: United States
facility: West Hills Hospital & Medical Center
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Denver
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian St. Luke's Medical Center
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Thornton
country: United States
facility: North Suburban Medical Center - JV
state: Colorado
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Aventura
country: United States
facility: Aventura Hospital
state: Florida
city: Bradenton
country: United States
facility: Blake Medical Center
state: Florida
city: Brandon
country: United States
facility: Brandon Regional
state: Florida
city: Brooksville
country: United States
facility: Oak Hill Hospital
state: Florida
city: Englewood
country: United States
facility: Englewood Community Hospital
state: Florida
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Fort Walton Beach
country: United States
facility: Fort Walton Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Hudson
country: United States
facility: Regional Medical Center Bayonet Point
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Poinciana Medical Center
state: Florida
city: Lake City
country: United States
facility: Lake City Medical Center
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Loxahatchee Groves
country: United States
facility: Palms West Hospital
state: Florida
city: Margate
country: United States
facility: Northwest Medical Center
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
city: Niceville
country: United States
facility: Twin Cities Hospital
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: West Marion Community Hospital
state: Florida
city: Okeechobee
country: United States
facility: Raulerson Hospital
state: Florida
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Medical Center
state: Florida
city: Pensacola
country: United States
facility: West Florida Hospital
state: Florida
city: Plantation
country: United States
facility: Plantation General Hospital
state: Florida
city: Plantation
country: United States
facility: Westside Regional Medical Center
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: St. Lucie Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: St. Petersburg General Hospital
state: Florida
city: Sanford
country: United States
facility: Central Florida Regional Hospital
state: Florida
city: Sarasota
country: United States
facility: Doctor's Hospital Sarasota
state: Florida
city: Sun City Center
country: United States
facility: South Bay Hospital
state: Florida
city: Tallahassee
country: United States
facility: Capital Regional Medical Center
state: Florida
city: Tamarac
country: United States
facility: University Hospital & Medical Center
state: Florida
city: Trinity
country: United States
facility: Medical Center of Trinity
state: Florida
city: West Palm Beach
country: United States
facility: JFK Medical Center - North Campus
state: Florida
city: Augusta
country: United States
facility: Doctor's Hospital Augusta
state: Georgia
city: Cartersville
country: United States
facility: Cartersville Medical Center
state: Georgia
city: Dublin
country: United States
facility: Fairview Park
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Centers - Main
state: Georgia
city: Macon
country: United States
facility: Coliseum Medical Centers - Northside
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Snellville
country: United States
facility: Eastside Medical Center
state: Georgia
city: Caldwell
country: United States
facility: West Valley Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional
state: Idaho
city: Terre Haute
country: United States
facility: Terre Haute Regional Hospital
state: Indiana
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Woodlawn Hospital
state: Kansas
city: Bowling Green
country: United States
facility: Greenview Regional Hospital
state: Kentucky
city: Alexandria
country: United States
facility: Rapides Regional Medical Center
state: Louisiana
city: Covington
country: United States
facility: Lakeview Regional Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: Gulfport
country: United States
facility: Garden Park Medical Center
state: Mississippi
city: Belton
country: United States
facility: Belton Regional Medical Center
state: Missouri
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lee's Summit
country: United States
facility: Lee's Summit Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital & Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Mountainview Hospital - Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Southern Hills Hospital - Vegas
state: Nevada
city: Derry
country: United States
facility: Parkland Medical Center
state: New Hampshire
city: Portsmouth
country: United States
facility: Portsmouth Regional Hospital
state: New Hampshire
city: Fredericksburg
country: United States
facility: Spotsylvania Regional Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Regional Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Summerville
country: United States
facility: Summerville Medical Center
state: South Carolina
city: Walterboro
country: United States
facility: Colleton Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge East Hospital
state: Tennessee
city: Hendersonville
country: United States
facility: Hendersonville Medical Center
state: Tennessee
city: Hermitage
country: United States
facility: Summit Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Stonecrest Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Skyline Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Southern Hills Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Medical Center of Arlington
state: Texas
city: Austin
country: United States
facility: South Austin Hospital
state: Texas
city: Austin
country: United States
facility: North Austin Medical Center
state: Texas
city: Brownsville
country: United States
facility: Valley Regional Medical Center
state: Texas
city: Conroe
country: United States
facility: Conroe Regional Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center - Doctor's
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center - The Heart Hospital
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Denton
country: United States
facility: Denton Regional Medical Center
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
city: El Paso
country: United States
facility: Del Sol Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Houston
country: United States
facility: East Houston Regional Medical Center
state: Texas
city: Houston
country: United States
facility: West Houston Medical Center
state: Texas
city: Irving
country: United States
facility: Las Colinas Medical Center
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Lewisville
country: United States
facility: Medical Center of Lewisville
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: McKinney
country: United States
facility: Medical Center of McKinney
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Hospital
state: Texas
city: Pasadena
country: United States
facility: Bayshore Medical Center
state: Texas
city: Plano
country: United States
facility: Medical Center of Plano
state: Texas
city: Round Rock
country: United States
facility: Round Rock Hospital
state: Texas
city: San Antonio
country: United States
facility: Metropolitan Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Specialty & Transplant Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Stone Oak Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: San Antonio
country: United States
facility: Northeast Methodist Hospital
state: Texas
city: Texas City
country: United States
facility: Mainland Medical Center
state: Texas
city: Webster
country: United States
facility: Clearlake Regional Medical Center
state: Texas
city: Bountiful
country: United States
facility: Lakeview Hospital
state: Utah
city: Ogden
country: United States
facility: Ogden Regional Medical Center
state: Utah
city: Orem
country: United States
facility: Timpanogos Regional Medical Center
state: Utah
city: Payson
country: United States
facility: Mountain View Hospital - Utah
state: Utah
city: Blacksburg
country: United States
facility: LewisGale Hospital - Montgomery
state: Virginia
city: Hopewell
country: United States
facility: John Randolph Medical Center
state: Virginia
city: Low Moor
country: United States
facility: LewisGale Hospital - Alleghany
state: Virginia
city: Pulaski
country: United States
facility: LewisGale Hospital - Pulaski
state: Virginia
city: Reston
country: United States
facility: Reston Hospital
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Retreat Campus
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Chippenham Campus)
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Johnston Willis Campus)
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Forest Campus
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Parham Campus
state: Virginia
city: Salem
country: United States
facility: LewisGale Medical Center
state: Virginia
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Richard Platt, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Susan Huang, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.