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)

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.

Study Overview

• Status: Completed
• Conditions: Methicillin Resistant Staphylococcus Aureus; Multi Drug Resistant Organisms; Healthcare Associated Infections
• Intervention / Treatment: Drug: Arm 2: Decolonization

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • West Hills, California, United States, 91307
      • West Hills Hospital & Medical Center
  • Colorado
    • Thornton, Colorado, United States, 80229
      • North Suburban Medical Center
  • Florida
    • Bradenton, Florida, United States, 34209
      • Blake Medical Center
    • Kissimmee, Florida, United States, 34741
      • Osceola Regional Medical Center
    • Loxahatchee Groves, Florida, United States, 33470
      • Palms West Hospital
    • Orange Park, Florida, United States, 32073
      • Orange Park Medical Center
    • Pensacola, Florida, United States, 32514
      • West Florida Hospital
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Saint Petersburg, Florida, United States, 33710
      • St. Petersburg General Hospital
    • Sun City Center, Florida, United States, 33573
      • South Bay Hospital
    • West Palm Beach, Florida, United States, 33407
      • West Palm Hospital
  • Georgia
    • Cartersville, Georgia, United States, 30120
      • Cartersville Medical Center
    • Macon, Georgia, United States, 31210
      • Coliseum Northside Hospital
    • Snellville, Georgia, United States, 30078
      • Eastside Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center
  • Louisiana
    • Lafayette, Louisiana, United States, 70506
      • Regional Medical Center of Acadiana
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Garden Park Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Lee's Summit, Missouri, United States, 64063
      • Lee's Summit Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital and Medical Center
    • Las Vegas, Nevada, United States, 89128
      • MountainView Hospital-Las Vegas
  • New Hampshire
    • Derry, New Hampshire, United States, 03038
      • Parkland Medical Center
    • Portsmouth, New Hampshire, United States, 03801
      • Portsmouth Regional Hospital
  • South Carolina
    • Walterboro, South Carolina, United States, 29488
      • Colleton Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Parkridge Medical Center
    • Chattanooga, Tennessee, United States, 37412
      • Parkridge East Hospital
    • Dickson, Tennessee, United States, 37055
      • TriStar Horizon Medical Center
    • Hendersonville, Tennessee, United States, 37075
      • Hendersonville Medical Center
    • Hermitage, Tennessee, United States, 37076
      • Summit Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's Medical Center
    • Brownsville, Texas, United States, 78526
      • Valley Regional Medical Center
    • Conroe, Texas, United States, 77304
      • Conroe Regional Medical Center
    • Corpus Christi, Texas, United States, 78411
      • Corpus Christi Medical Center
    • El Paso, Texas, United States, 79902
      • Las Palmas Medical Center
    • Fort Worth, Texas, United States, 76104
      • Plaza Medical Center of Fort Worth
    • Irving, Texas, United States, 75039
      • Las Colinas Medical Center
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
    • Live Oak, Texas, United States, 78233
      • Northeast Methodist Hospital
    • McAllen, Texas, United States, 78503
      • Rio Grande Regional Hospital
    • North Richland Hills, Texas, United States, 76180
      • North Hills Hospital
    • Plano, Texas, United States, 75075
      • Medical Center of Plano
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Methodist Specialty and Transplant Hospital
    • San Antonio, Texas, United States, 78258
      • Methodist Stone Oak Hospital
    • Webster, Texas, United States, 77598
      • Clear Lake Regional Medical Center
  • Utah
    • Orem, Utah, United States, 84057
      • Timpanogos Regional Hospital
  • Virginia
    • Hopewell, Virginia, United States, 23860
      • John Randolph Medical Center
    • Low Moor, Virginia, United States, 24457
      • LewisGale Hospital-Alleghany
    • Reston, Virginia, United States, 20190
      • Reston Hospital Center
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors' Hospital
    • Richmond, Virginia, United States, 23225
      • Chippenham Johnston Willis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All HCA hospitals that reside in the United States
• Note: Unit of randomization is the hospital, but the participants are hospital units

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm 1: Usual Care; Routine policy for showering or bathing non-critical care patients
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gram-negative Multi-drug Resistant Organism Clinical Cultures	Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge	21 months
All-cause Bloodstream Infections	All-cause bloodstream infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.	21 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Tract Infections	Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge	21 months
Blood Culture Contamination	Blood culture contamination	21 months
Clostridium Difficile Infection	Clostridium difficile Infection attributable to participating units	21 months
30-Day Infectious Readmissions	30-Day Infectious Readmissions among patients in participating units	21 months
Emergence of Resistance to Chlorhexidine or Mupirocin	Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units	21 months
Cost Effectiveness	Cost effectiveness of routine care vs decolonization	21 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Harvard Medical School (HMS and HSDM); National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH); Centers for Disease Control and Prevention; Harvard Pilgrim Health Care; Rush University; John H. Stroger Hospital; Hospital Corporation of America (HCA)
• Investigators: Study Director: Ken Kleinman, ScD, University of Massachusetts, Amherst; Study Director: Edward Septimus, MD, Hospital Corporation of America (HCA); 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

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet. 2019 Mar 23;393(10177):1204. Lancet. 2019 Aug 10;394(10197):470.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: MRSA; HAI; VRE
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: 367981; UH2AT007769 (U.S. NIH Grant/Contract); UH3AI113337 (U.S. NIH Grant/Contract)