Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02063867
Previous Study | Return to List | Next Study

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
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

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

Layout table for study information
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

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.





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



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.


Layout table for eligibility information
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

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


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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 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:
Layout table for MeSH terms
Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action