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Trial record 1 of 1 for:    NCT02063867
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Active Bathing to Eliminate Infection (ABATE Infection) Trial (ABATE)

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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
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
John H. Stroger Hospital
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

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 14, 2014
Results First Submitted Date  ICMJE April 29, 2019
Results First Posted Date  ICMJE July 12, 2019
Last Update Posted Date July 12, 2019
Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
MRSA and VRE Clinical Cultures [ Time Frame: 18 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
Change History Complete list of historical versions of study NCT02063867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • Gram-negative Multi-drug Resistant Organism Clinical Cultures [ Time Frame: 18 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
  • All-cause Bloodstream Infections [ Time Frame: 18 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 subsets of gram positive (GP) and gram negative (GN) MDROs as well as key pathogens such as S. aureus.
Current Other Pre-specified Outcome Measures
 (submitted: June 14, 2019)
  • 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
  • Blood Culture Contamination [ Time Frame: 21 months ]
    Blood culture contamination
  • Clostridium Difficile Infection [ Time Frame: 21 months ]
    Clostridium difficile Infection attributable to participating units
  • 30-Day Infectious Readmissions [ Time Frame: 21 months ]
    30-Day Infectious Readmissions among patients in participating units
  • 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
  • Cost Effectiveness [ Time Frame: 21 months ]
    Cost effectiveness of routine care vs decolonization
Original Other Pre-specified Outcome Measures
 (submitted: February 12, 2014)
  • Urinary Tract Infections [ Time Frame: 18 months ]
    Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge
  • Blood Culture Contamination [ Time Frame: 18 months ]
    Blood culture contamination
  • Clostridium Difficile Infection [ Time Frame: 18 months ]
    Clostridium difficile Infection attributable to participating units
  • 30-Day Infectious Readmissions [ Time Frame: 18 months ]
    30-Day Infectious Readmissions among patients in participating units
  • Emergence of Resistance to Chlorhexidine or Mupirocin [ Time Frame: 18 months ]
    Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units
  • Cost Effectiveness [ Time Frame: 18 months ]
    Cost effectiveness of routine care vs decolonization
 
Descriptive Information
Brief Title  ICMJE Active Bathing to Eliminate Infection (ABATE Infection) Trial
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Healthcare Associated Infections
  • Methicillin Resistant Staphylococcus Aureus
  • Multi Drug Resistant Organisms
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Drug: Arm 2: Decolonization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2014)
53
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063867
Other Study ID Numbers  ICMJE 367981
UH2AT007769 ( U.S. NIH Grant/Contract )
UH3AI113337 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Huang, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE
  • Harvard Medical School
  • Harvard Pilgrim Health Care
  • Hospital Corporation of America (HCA)
  • Rush University
  • John H. Stroger Hospital
  • Centers for Disease Control and Prevention
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
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
PRS Account University of California, Irvine
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP