Active Bathing to Eliminate Infection (ABATE Infection) Trial
ABATE
Cluster-Randomized Controlled Trial of Hospitals to Reduce Healthcare-Associated Infections and Readmissions Through Routine Bathing With Antiseptic Soap and Targeted Use of Nasal Antibiotic Ointment (ABATE Infection Trial)
3 other identifiers
interventional
53
1 country
52
Brief Summary
The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedResults Posted
Study results publicly available
July 12, 2019
CompletedJuly 12, 2019
June 1, 2019
4.8 years
February 12, 2014
April 29, 2019
June 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRSA and VRE Clinical Cultures
Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \>2 days into a participating unit stay through 2 days following unit discharge
21 months
Secondary Outcomes (2)
Gram-negative Multi-drug Resistant Organism Clinical Cultures
21 months
All-cause Bloodstream Infections
21 months
Other Outcomes (6)
Urinary Tract Infections
21 months
Blood Culture Contamination
21 months
Clostridium Difficile Infection
21 months
- +3 more other outcomes
Study Arms (2)
Arm 1: Usual Care
NO INTERVENTIONRoutine policy for showering or bathing non-critical care patients
Arm 2: Decolonization
ACTIVE COMPARATORDaily 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
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
You may qualify if:
- All HCA hospitals that reside in the United States
- Note: Unit of randomization is the hospital, but the participants are hospital units
You may not qualify if:
- Non-critical care units where chlorhexidine bathing or decolonization for MRSA+ non-critical care patients is routine
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Harvard Medical School (HMS and HSDM)collaborator
- Harvard Pilgrim Health Carecollaborator
- Hospital Corporation of Americacollaborator
- Rush Universitycollaborator
- Cook County Healthcollaborator
- Centers for Disease Control and Preventioncollaborator
- National Institutes of Health (NIH)collaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
Study Sites (52)
West Hills Hospital & Medical Center
West Hills, California, 91307, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Blake Medical Center
Bradenton, Florida, 34209, United States
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Palms West Hospital
Loxahatchee Groves, Florida, 33470, United States
Orange Park Medical Center
Orange Park, Florida, 32073, United States
West Florida Hospital
Pensacola, Florida, 32514, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
St. Petersburg General Hospital
St. Petersburg, Florida, 33710, United States
South Bay Hospital
Sun City Center, Florida, 33573, United States
West Palm Hospital
West Palm Beach, Florida, 33407, United States
Cartersville Medical Center
Cartersville, Georgia, 30120, United States
Coliseum Northside Hospital
Macon, Georgia, 31210, United States
Eastside Medical Center
Snellville, Georgia, 30078, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Regional Medical Center of Acadiana
Lafayette, Louisiana, 70506, United States
Garden Park Medical Center
Gulfport, Mississippi, 39503, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
MountainView Hospital-Las Vegas
Las Vegas, Nevada, 89128, United States
Parkland Medical Center
Derry, New Hampshire, 03038, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03801, United States
Colleton Medical Center
Walterboro, South Carolina, 29488, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
Parkridge East Hospital
Chattanooga, Tennessee, 37412, United States
TriStar Horizon Medical Center
Dickson, Tennessee, 37055, United States
Hendersonville Medical Center
Hendersonville, Tennessee, 37075, United States
Summit Medical Center
Hermitage, Tennessee, 37076, United States
St. David's Medical Center
Austin, Texas, 78705, United States
Valley Regional Medical Center
Brownsville, Texas, 78526, United States
Conroe Regional Medical Center
Conroe, Texas, 77304, United States
Corpus Christi Medical Center
Corpus Christi, Texas, 78411, United States
Las Palmas Medical Center
El Paso, Texas, 79902, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, 76104, United States
Las Colinas Medical Center
Irving, Texas, 75039, United States
Kingwood Medical Center
Kingwood, Texas, 77339, United States
Northeast Methodist Hospital
Live Oak, Texas, 78233, United States
Rio Grande Regional Hospital
McAllen, Texas, 78503, United States
North Hills Hospital
North Richland Hills, Texas, 76180, United States
Medical Center of Plano
Plano, Texas, 75075, United States
Methodist Texsan Hospital
San Antonio, Texas, 78201, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
Methodist Specialty and Transplant Hospital
San Antonio, Texas, 78229, United States
Methodist Stone Oak Hospital
San Antonio, Texas, 78258, United States
Clear Lake Regional Medical Center
Webster, Texas, 77598, United States
Timpanogos Regional Hospital
Orem, Utah, 84057, United States
John Randolph Medical Center
Hopewell, Virginia, 23860, United States
LewisGale Hospital-Alleghany
Low Moor, Virginia, 24457, United States
Reston Hospital Center
Reston, Virginia, 20190, United States
Chippenham Johnston Willis Medical Center
Richmond, Virginia, 23225, United States
Henrico Doctors' Hospital
Richmond, Virginia, 23229, United States
Related Publications (2)
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.
PMID: 30850112DERIVEDJohnson 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.
PMID: 26772801DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention
- Organization
- University of California, Irvine
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Huang, MD MPH
University of California, Irvine
- STUDY DIRECTOR
Ken Kleinman, ScD
University of Massachusetts, Amherst
- STUDY DIRECTOR
Edward Septimus, MD
Hospital Corporation of America
- STUDY DIRECTOR
Jason Hickok, MBA, RN
Hospital Corporation of America
- STUDY DIRECTOR
Julia Moody, MS
Hospital Corporation of America
- STUDY DIRECTOR
Mary Hayden, MD
Rush University
- STUDY DIRECTOR
Robert Weinstein, MD
John Stroger Hospital
- STUDY DIRECTOR
John Jernigan, MD MS
Centers for Disease Control and Prevention
- STUDY DIRECTOR
Jonathan Perlin, MD PhD
Hospital Corporation of America
- STUDY DIRECTOR
Daniel Gillen, PhD
University of California, Irvine
- STUDY DIRECTOR
Grace Lee, MD MPH
Harvard Pilgrim Health Care Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor and Medical Director of Epidemiology and Infection Prevention
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 14, 2014
Study Start
April 1, 2014
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
July 12, 2019
Results First Posted
July 12, 2019
Record last verified: 2019-06