Staphylococcus Aureus Clinical 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
| Verified date | January 2024 |
| Source | Harvard Pilgrim Health Care |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 353323 |
| Est. completion date | November 6, 2023 |
| Est. primary completion date | November 6, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rapides Regional Medical Center | Alexandria | Louisiana |
| United States | Medical Center of Arlington | Arlington | Texas |
| United States | JFK Medical Center | Atlantis | Florida |
| United States | Doctor's Hospital Augusta | Augusta | Georgia |
| United States | The Medical Center of Aurora | Aurora | Colorado |
| United States | North Austin Medical Center | Austin | Texas |
| United States | South Austin Hospital | Austin | Texas |
| United States | Aventura Hospital | Aventura | Florida |
| United States | Belton Regional Medical Center | Belton | Missouri |
| United States | LewisGale Hospital - Montgomery | Blacksburg | Virginia |
| United States | Lakeview Hospital | Bountiful | Utah |
| United States | Greenview Regional Hospital | Bowling Green | Kentucky |
| United States | Blake Medical Center | Bradenton | Florida |
| United States | Brandon Regional | Brandon | Florida |
| United States | Oak Hill Hospital | Brooksville | Florida |
| United States | Valley Regional Medical Center | Brownsville | Texas |
| United States | West Valley Medical Center | Caldwell | Idaho |
| United States | Cartersville Medical Center | Cartersville | Georgia |
| United States | Trident Regional Medical Center | Charleston | South Carolina |
| United States | Parkridge East Hospital | Chattanooga | Tennessee |
| United States | Parkridge Medical Center | Chattanooga | Tennessee |
| United States | Conroe Regional Medical Center | Conroe | Texas |
| United States | Corpus Christi Medical Center - Doctor's | Corpus Christi | Texas |
| United States | Corpus Christi Medical Center - The Heart Hospital | Corpus Christi | Texas |
| United States | Lakeview Regional Medical Center | Covington | Louisiana |
| United States | Medical City Dallas Hospital | Dallas | Texas |
| United States | Denton Regional Medical Center | Denton | Texas |
| United States | Presbyterian St. Luke's Medical Center | Denver | Colorado |
| United States | Rose Medical Center | Denver | Colorado |
| United States | Sky Ridge Medical Center | Denver | Colorado |
| United States | Swedish Medical Center | Denver | Colorado |
| United States | Parkland Medical Center | Derry | New Hampshire |
| United States | Fairview Park | Dublin | Georgia |
| United States | Del Sol Medical Center | El Paso | Texas |
| United States | Las Palmas Medical Center | El Paso | Texas |
| United States | Englewood Community Hospital | Englewood | Florida |
| United States | Lawnwood Regional Medical Center | Fort Pierce | Florida |
| United States | Fort Walton Medical Center | Fort Walton Beach | Florida |
| United States | Plaza Medical Center of Fort Worth | Fort Worth | Texas |
| United States | Spotsylvania Regional Medical Center | Fredericksburg | Pennsylvania |
| United States | North Florida Regional Medical Center | Gainesville | Florida |
| United States | Garden Park Medical Center | Gulfport | Mississippi |
| United States | Hendersonville Medical Center | Hendersonville | Tennessee |
| United States | Summit Medical Center | Hermitage | Tennessee |
| United States | John Randolph Medical Center | Hopewell | Virginia |
| United States | East Houston Regional Medical Center | Houston | Texas |
| United States | West Houston Medical Center | Houston | Texas |
| United States | Regional Medical Center Bayonet Point | Hudson | Florida |
| United States | Eastern Idaho Regional | Idaho Falls | Idaho |
| United States | Centerpoint Medical Center | Independence | Missouri |
| United States | Las Colinas Medical Center | Irving | Texas |
| United States | Memorial Hospital Jacksonville | Jacksonville | Florida |
| United States | Research Medical Center | Kansas City | Missouri |
| United States | Kingwood Medical Center | Kingwood | Texas |
| United States | Osceola Regional Medical Center | Kissimmee | Florida |
| United States | Poinciana Medical Center | Kissimmee | Florida |
| United States | Lake City Medical Center | Lake City | Florida |
| United States | Largo Medical Center | Largo | Florida |
| United States | Mountainview Hospital - Vegas | Las Vegas | Nevada |
| United States | Southern Hills Hospital - Vegas | Las Vegas | Nevada |
| United States | Sunrise Hospital & Medical Center | Las Vegas | Nevada |
| United States | Lee's Summit Medical Center | Lee's Summit | Missouri |
| United States | Medical Center of Lewisville | Lewisville | Texas |
| United States | LewisGale Hospital - Alleghany | Low Moor | Virginia |
| United States | Palms West Hospital | Loxahatchee Groves | Florida |
| United States | Coliseum Medical Centers - Main | Macon | Georgia |
| United States | Coliseum Medical Centers - Northside | Macon | Georgia |
| United States | Northwest Medical Center | Margate | Florida |
| United States | Rio Grande Regional Hospital | McAllen | Texas |
| United States | Medical Center of McKinney | McKinney | Texas |
| United States | Kendall Regional Medical Center | Miami | Florida |
| United States | Mercy Hospital | Miami | Florida |
| United States | Grand Strand Regional Medical Center | Myrtle Beach | South Carolina |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | Skyline Medical Center | Nashville | Tennessee |
| United States | Southern Hills Medical Center | Nashville | Tennessee |
| United States | Stonecrest Medical Center | Nashville | Tennessee |
| United States | Tulane University Hospital & Clinic | New Orleans | Louisiana |
| United States | Twin Cities Hospital | Niceville | Florida |
| United States | North Hills Hospital | North Richland Hills | Texas |
| United States | Ocala Regional Medical Center | Ocala | Florida |
| United States | West Marion Community Hospital | Ocala | Florida |
| United States | Ogden Regional Medical Center | Ogden | Utah |
| United States | Raulerson Hospital | Okeechobee | Florida |
| United States | Orange Park Medical Center | Orange Park | Florida |
| United States | Timpanogos Regional Medical Center | Orem | Utah |
| United States | Menorah Medical Center | Overland Park | Kansas |
| United States | Overland Park Regional Medical Center | Overland Park | Kansas |
| United States | Gulf Coast Medical Center | Panama City | Florida |
| United States | Bayshore Medical Center | Pasadena | Texas |
| United States | Mountain View Hospital - Utah | Payson | Utah |
| United States | West Florida Hospital | Pensacola | Florida |
| United States | Medical Center of Plano | Plano | Texas |
| United States | Plantation General Hospital | Plantation | Florida |
| United States | Westside Regional Medical Center | Plantation | Florida |
| United States | Fawcett Memorial Hospital | Port Charlotte | Florida |
| United States | St. Lucie Medical Center | Port Saint Lucie | Florida |
| United States | Portsmouth Regional Hospital | Portsmouth | New Hampshire |
| United States | LewisGale Hospital - Pulaski | Pulaski | Virginia |
| United States | Reston Hospital | Reston | Virginia |
| United States | CJW Medical Center (Chippenham Campus) | Richmond | Virginia |
| United States | CJW Medical Center (Johnston Willis Campus) | Richmond | Virginia |
| United States | Henrico Doctors' Hospital - Forest Campus | Richmond | Virginia |
| United States | Henrico Doctors' Hospital - Parham Campus | Richmond | Virginia |
| United States | Henrico Doctors' Hospital - Retreat Campus | Richmond | Virginia |
| United States | Riverside Community Hospital | Riverside | California |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | Round Rock Hospital | Round Rock | Texas |
| United States | Northside Hospital | Saint Petersburg | Florida |
| United States | St. Petersburg General Hospital | Saint Petersburg | Florida |
| United States | LewisGale Medical Center | Salem | Virginia |
| United States | Methodist Hospital | San Antonio | Texas |
| United States | Methodist Specialty & Transplant Hospital | San Antonio | Texas |
| United States | Methodist Stone Oak Hospital | San Antonio | Texas |
| United States | Methodist Texsan Hospital | San Antonio | Texas |
| United States | Metropolitan Methodist Hospital | San Antonio | Texas |
| United States | Northeast Methodist Hospital | San Antonio | Texas |
| United States | Good Samaritan Hospital | San Jose | California |
| United States | Regional Medical Center of San Jose | San Jose | California |
| United States | Central Florida Regional Hospital | Sanford | Florida |
| United States | Doctor's Hospital Sarasota | Sarasota | Florida |
| United States | Eastside Medical Center | Snellville | Georgia |
| United States | Summerville Medical Center | Summerville | South Carolina |
| United States | South Bay Hospital | Sun City Center | Florida |
| United States | Capital Regional Medical Center | Tallahassee | Florida |
| United States | University Hospital & Medical Center | Tamarac | Florida |
| United States | Terre Haute Regional Hospital | Terre Haute | Indiana |
| United States | Mainland Medical Center | Texas City | Texas |
| United States | North Suburban Medical Center - JV | Thornton | Colorado |
| United States | Los Robles Regional Medical Center | Thousand Oaks | California |
| United States | Medical Center of Trinity | Trinity | Florida |
| United States | Colleton Medical Center | Walterboro | South Carolina |
| United States | Clearlake Regional Medical Center | Webster | Texas |
| United States | West Hills Hospital & Medical Center | West Hills | California |
| United States | JFK Medical Center - North Campus | West Palm Beach | Florida |
| United States | Wesley Medical Center | Wichita | Kansas |
| United States | Wesley Woodlawn Hospital | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Harvard Pilgrim Health Care | Centers for Disease Control and Prevention, Hospital Corporation of America, Rush University, University of California, Irvine, University of Massachusetts, Amherst |
United States,
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, — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 |
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