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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02063867
First Posted: February 14, 2014
Last Update Posted: August 17, 2017
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.
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
NIH Common Fund
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine
  Purpose

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 Intervention
Healthcare Associated Infections Methicillin Resistant Staphylococcus Aureus Multi Drug Resistant Organisms Drug: Arm 2: Decolonization

Study Type: Interventional
Study Design: 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)

Further study details as provided by Susan Huang, University of California, Irvine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 53
Study Start Date: April 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
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


  Show 52 Study Locations
Sponsors and Collaborators
University of California, Irvine
Harvard Medical School
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
John H. Stroger Hospital
Centers for Disease Control and Prevention
NIH Common Fund
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Huang, Associate Professor and Medical Director of Epidemiology and Infection Prevention, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02063867     History of Changes
Other Study ID Numbers: 367981
UH2AT007769 ( U.S. NIH Grant/Contract )
UH3AI113337 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2014
First Posted: February 14, 2014
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Susan Huang, University of California, Irvine:
HAI
MRSA
VRE

Additional relevant MeSH terms:
Infection
Communicable Diseases
Staphylococcal Infections
Cross Infection
Gram-Positive Bacterial Infections
Bacterial Infections
Iatrogenic Disease
Disease Attributes
Pathologic Processes