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Active Bathing to Eliminate Infection (ABATE Infection) Trial (ABATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02063867
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Harvard Medical School (HMS and HSDM)
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
Cook County Health
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthcare Associated Infections Methicillin Resistant Staphylococcus Aureus Multi Drug Resistant Organisms Drug: Arm 2: Decolonization Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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)
Study Start Date : April 2014
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. MRSA and VRE Clinical Cultures [ Time Frame: 21 months ]
    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


Secondary Outcome Measures :
  1. Gram-negative Multi-drug Resistant Organism Clinical Cultures [ Time Frame: 21 months ]
    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

  2. All-cause Bloodstream Infections [ Time Frame: 21 months ]
    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.


Other Outcome Measures:
  1. Urinary Tract Infections [ Time Frame: 21 months ]
    Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge

  2. Blood Culture Contamination [ Time Frame: 21 months ]
    Blood culture contamination

  3. Clostridium Difficile Infection [ Time Frame: 21 months ]
    Clostridium difficile Infection attributable to participating units

  4. 30-Day Infectious Readmissions [ Time Frame: 21 months ]
    30-Day Infectious Readmissions among patients in participating units

  5. Emergence of Resistance to Chlorhexidine or Mupirocin [ Time Frame: 21 months ]
    Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units

  6. Cost Effectiveness [ Time Frame: 21 months ]
    Cost effectiveness of routine care vs decolonization


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063867


Locations
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Sponsors and Collaborators
University of California, Irvine
Harvard Medical School (HMS and HSDM)
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
Cook County Health
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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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 (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
  Study Documents (Full-Text)

Documents provided by Susan Huang, University of California, Irvine:
Study Protocol  [PDF] June 30, 2015
Statistical Analysis Plan  [PDF] June 30, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susan Huang, Associate Professor and Medical Director of Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02063867    
Other Study ID Numbers: 367981
UH2AT007769 ( U.S. NIH Grant/Contract )
UH3AI113337 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2014    Key Record Dates
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019
Last Verified: June 2019
Keywords provided by Susan Huang, University of California, Irvine:
HAI
MRSA
VRE
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Cross Infection
 Disease Attributes
Pathologic Processes
Iatrogenic Disease