Active Bathing to Eliminate Infection (ABATE Infection) Trial
NCT ID: NCT02063867
Last Updated: 2019-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2014-04-30
2019-02-28
Brief Summary
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* Arm 1: Routine Care Routine policy for showering/bathing
* Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen
Note that enrolled "subjects" represents 53 individual HCA Hospitals (representing \~190 non-critical care units) that have been randomized.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm 1: Usual Care
Routine policy for showering or bathing non-critical care patients
No interventions assigned to this group
Arm 2: Decolonization
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
Arm 2: Decolonization
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
Interventions
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Arm 2: Decolonization
Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.
Eligibility Criteria
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Inclusion Criteria
* Note: Unit of randomization is the hospital, but the participants are hospital units
Exclusion Criteria
* Pediatric, peri-partum, rehabilitation, psychiatry, and BMT units
* Units with \>30% cardiac or hip/knee orthopedic surgeries
* Unit average length of stay \<2 days
* Patients \<12 years-old
* Patients with known allergy to mupirocin or chlorhexidine
12 Years
ALL
No
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Harvard Pilgrim Health Care
OTHER
Hospital Corporation of America
INDUSTRY
Rush University
OTHER
Cook County Health
OTHER_GOV
Centers for Disease Control and Prevention
FED
National Institutes of Health (NIH)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
University of California, Irvine
OTHER
Responsible Party
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Susan Huang
Associate Professor and Medical Director of Epidemiology and Infection Prevention
Principal Investigators
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Susan Huang, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine
Ken Kleinman, ScD
Role: STUDY_DIRECTOR
University of Massachusetts, Amherst
Edward Septimus, MD
Role: STUDY_DIRECTOR
Hospital Corporation of America
Jason Hickok, MBA, RN
Role: STUDY_DIRECTOR
Hospital Corporation of America
Julia Moody, MS
Role: STUDY_DIRECTOR
Hospital Corporation of America
Mary Hayden, MD
Role: STUDY_DIRECTOR
Rush University
Robert Weinstein, MD
Role: STUDY_DIRECTOR
John Stroger Hospital
John Jernigan, MD MS
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Jonathan Perlin, MD PhD
Role: STUDY_DIRECTOR
Hospital Corporation of America
Daniel Gillen, PhD
Role: STUDY_DIRECTOR
University of California, Irvine
Grace Lee, MD MPH
Role: STUDY_DIRECTOR
Harvard Pilgrim Health Care Institute
Locations
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West Hills Hospital & Medical Center
West Hills, California, United States
North Suburban Medical Center
Thornton, Colorado, United States
Blake Medical Center
Bradenton, Florida, United States
Osceola Regional Medical Center
Kissimmee, Florida, United States
Palms West Hospital
Loxahatchee Groves, Florida, United States
Orange Park Medical Center
Orange Park, Florida, United States
West Florida Hospital
Pensacola, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
St. Petersburg General Hospital
St. Petersburg, Florida, United States
South Bay Hospital
Sun City Center, Florida, United States
West Palm Hospital
West Palm Beach, Florida, United States
Cartersville Medical Center
Cartersville, Georgia, United States
Coliseum Northside Hospital
Macon, Georgia, United States
Eastside Medical Center
Snellville, Georgia, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Regional Medical Center of Acadiana
Lafayette, Louisiana, United States
Garden Park Medical Center
Gulfport, Mississippi, United States
Research Medical Center
Kansas City, Missouri, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
MountainView Hospital-Las Vegas
Las Vegas, Nevada, United States
Parkland Medical Center
Derry, New Hampshire, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States
Colleton Medical Center
Walterboro, South Carolina, United States
Parkridge Medical Center
Chattanooga, Tennessee, United States
Parkridge East Hospital
Chattanooga, Tennessee, United States
TriStar Horizon Medical Center
Dickson, Tennessee, United States
Hendersonville Medical Center
Hendersonville, Tennessee, United States
Summit Medical Center
Hermitage, Tennessee, United States
St. David's Medical Center
Austin, Texas, United States
Valley Regional Medical Center
Brownsville, Texas, United States
Conroe Regional Medical Center
Conroe, Texas, United States
Corpus Christi Medical Center
Corpus Christi, Texas, United States
Las Palmas Medical Center
El Paso, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
Las Colinas Medical Center
Irving, Texas, United States
Kingwood Medical Center
Kingwood, Texas, United States
Northeast Methodist Hospital
Live Oak, Texas, United States
Rio Grande Regional Hospital
McAllen, Texas, United States
North Hills Hospital
North Richland Hills, Texas, United States
Medical Center of Plano
Plano, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States
Methodist Stone Oak Hospital
San Antonio, Texas, United States
Clear Lake Regional Medical Center
Webster, Texas, United States
Timpanogos Regional Hospital
Orem, Utah, United States
John Randolph Medical Center
Hopewell, Virginia, United States
LewisGale Hospital-Alleghany
Low Moor, Virginia, United States
Reston Hospital Center
Reston, Virginia, United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia, United States
Henrico Doctors' Hospital
Richmond, Virginia, United States
Countries
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References
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Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Heim L, Gombosev A, Avery TR, Haffenreffer K, Shimelman L, Hayden MK, Weinstein RA, Spencer-Smith C, Kaganov RE, Murphy MV, Forehand T, Lankiewicz J, Coady MH, Portillo L, Sarup-Patel J, Jernigan JA, Perlin JB, Platt R; ABATE Infection trial team. Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet. 2019 Mar 23;393(10177):1205-1215. doi: 10.1016/S0140-6736(18)32593-5. Epub 2019 Mar 5.
Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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