Trial record 1 of 1 for:    NCT02063867
Previous Study | Return to List | Next Study

Active Bathing to Eliminate Infection (ABATE Infection) Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California Irvine School of Medicine
Harvard Medical School
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
John H. Stroger Hospital
Information provided by (Responsible Party):
Susan Huang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02063867
First received: February 12, 2014
Last updated: June 27, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of California, Irvine:

Primary Outcome Measures:
  • MRSA and VRE clinical cultures [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood culture contamination

  • Clostridium difficile Infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clostridium difficile Infection attributable to participating units

  • 30-Day Infectious Readmissions [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    30-Day Infectious Readmissions among patients in participating units

  • Emergence of resistance to chlorhexidine or mupirocin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cost effectiveness of routine care vs decolonization


Estimated Enrollment: 53
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063867

  Show 52 Study Locations
Sponsors and Collaborators
University of California, Irvine
University of California Irvine School of Medicine
Harvard Medical School
Harvard Pilgrim Health Care
Hospital Corporation of America (HCA)
Rush University
John H. Stroger Hospital
Investigators
Principal Investigator: Susan Huang, MD MPH University of California Irvine School of Medicine
Study Director: Ken Kleinman, ScD Harvard Medical School/ Harvard Pilgrim Health Care Inst.
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
  More Information

No publications provided

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
Study First Received: February 12, 2014
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 19, 2014