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

Primary Purpose

Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 2: Decolonization
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthcare Associated Infections focused on measuring HAI, MRSA, VRE

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Hills Hospital & Medical Center
  • North Suburban Medical Center
  • Blake Medical Center
  • Osceola Regional Medical Center
  • Palms West Hospital
  • Orange Park Medical Center
  • West Florida Hospital
  • Northside Hospital
  • St. Petersburg General Hospital
  • South Bay Hospital
  • West Palm Hospital
  • Cartersville Medical Center
  • Coliseum Northside Hospital
  • Eastside Medical Center
  • Overland Park Regional Medical Center
  • Regional Medical Center of Acadiana
  • Garden Park Medical Center
  • Research Medical Center
  • Lee's Summit Medical Center
  • Sunrise Hospital and Medical Center
  • MountainView Hospital-Las Vegas
  • Parkland Medical Center
  • Portsmouth Regional Hospital
  • Colleton Medical Center
  • Parkridge Medical Center
  • Parkridge East Hospital
  • TriStar Horizon Medical Center
  • Hendersonville Medical Center
  • Summit Medical Center
  • St. David's Medical Center
  • Valley Regional Medical Center
  • Conroe Regional Medical Center
  • Corpus Christi Medical Center
  • Las Palmas Medical Center
  • Plaza Medical Center of Fort Worth
  • Las Colinas Medical Center
  • Kingwood Medical Center
  • Northeast Methodist Hospital
  • Rio Grande Regional Hospital
  • North Hills Hospital
  • Medical Center of Plano
  • Methodist Texsan Hospital
  • Methodist Hospital
  • Methodist Specialty and Transplant Hospital
  • Methodist Stone Oak Hospital
  • Clear Lake Regional Medical Center
  • Timpanogos Regional Hospital
  • John Randolph Medical Center
  • LewisGale Hospital-Alleghany
  • Reston Hospital Center
  • Chippenham Johnston Willis Medical Center
  • Henrico Doctors' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm 1: Usual Care

Arm 2: Decolonization

Arm Description

Routine policy for showering or bathing non-critical care patients

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.

Outcomes

Primary Outcome Measures

MRSA and VRE Clinical Cultures
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
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
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.

Full Information

First Posted
February 12, 2014
Last Updated
June 14, 2019
Sponsor
University of California, Irvine
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)
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1. Study Identification

Unique Protocol Identification Number
NCT02063867
Brief Title
Active Bathing to Eliminate Infection (ABATE Infection) Trial
Acronym
ABATE
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
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)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infections, Methicillin Resistant Staphylococcus Aureus, Multi Drug Resistant Organisms
Keywords
HAI, MRSA, VRE

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Usual Care
Arm Type
No Intervention
Arm Description
Routine policy for showering or bathing non-critical care patients
Arm Title
Arm 2: Decolonization
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Arm 2: Decolonization
Intervention Description
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 Measure Information:
Title
MRSA and VRE Clinical Cultures
Description
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
Time Frame
21 months
Secondary Outcome Measure Information:
Title
Gram-negative Multi-drug Resistant Organism Clinical Cultures
Description
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
Time Frame
21 months
Title
All-cause Bloodstream Infections
Description
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.
Time Frame
21 months
Other Pre-specified Outcome Measures:
Title
Urinary Tract Infections
Description
Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge
Time Frame
21 months
Title
Blood Culture Contamination
Description
Blood culture contamination
Time Frame
21 months
Title
Clostridium Difficile Infection
Description
Clostridium difficile Infection attributable to participating units
Time Frame
21 months
Title
30-Day Infectious Readmissions
Description
30-Day Infectious Readmissions among patients in participating units
Time Frame
21 months
Title
Emergence of Resistance to Chlorhexidine or Mupirocin
Description
Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units
Time Frame
21 months
Title
Cost Effectiveness
Description
Cost effectiveness of routine care vs decolonization
Time Frame
21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Huang, MD MPH
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ken Kleinman, ScD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Edward Septimus, MD
Organizational Affiliation
Hospital Corporation of America (HCA)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jason Hickok, MBA, RN
Organizational Affiliation
Hospital Corporation of America
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Julia Moody, MS
Organizational Affiliation
Hospital Corporation of America
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mary Hayden, MD
Organizational Affiliation
Rush University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Weinstein, MD
Organizational Affiliation
John Stroger Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Jernigan, MD MS
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jonathan Perlin, MD PhD
Organizational Affiliation
Hospital Corporation of America
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Gillen, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Grace Lee, MD MPH
Organizational Affiliation
Harvard Pilgrim Health Care Institute
Official's Role
Study Director
Facility Information:
Facility Name
West Hills Hospital & Medical Center
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Blake Medical Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Palms West Hospital
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Orange Park Medical Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
West Florida Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Northside Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
St. Petersburg General Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
South Bay Hospital
City
Sun City Center
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Facility Name
West Palm Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Cartersville Medical Center
City
Cartersville
State/Province
Georgia
ZIP/Postal Code
30120
Country
United States
Facility Name
Coliseum Northside Hospital
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Eastside Medical Center
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Overland Park Regional Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Regional Medical Center of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Garden Park Medical Center
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Lee's Summit Medical Center
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64063
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
MountainView Hospital-Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Parkland Medical Center
City
Derry
State/Province
New Hampshire
ZIP/Postal Code
03038
Country
United States
Facility Name
Portsmouth Regional Hospital
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Colleton Medical Center
City
Walterboro
State/Province
South Carolina
ZIP/Postal Code
29488
Country
United States
Facility Name
Parkridge Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Parkridge East Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37412
Country
United States
Facility Name
TriStar Horizon Medical Center
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Hendersonville Medical Center
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Facility Name
Summit Medical Center
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Valley Regional Medical Center
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
Conroe Regional Medical Center
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Corpus Christi Medical Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Las Palmas Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Plaza Medical Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Las Colinas Medical Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Facility Name
Kingwood Medical Center
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Northeast Methodist Hospital
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Rio Grande Regional Hospital
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
North Hills Hospital
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States
Facility Name
Medical Center of Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Methodist Texsan Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Methodist Specialty and Transplant Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Methodist Stone Oak Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Clear Lake Regional Medical Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Timpanogos Regional Hospital
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
John Randolph Medical Center
City
Hopewell
State/Province
Virginia
ZIP/Postal Code
23860
Country
United States
Facility Name
LewisGale Hospital-Alleghany
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
Reston Hospital Center
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
Facility Name
Chippenham Johnston Willis Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Henrico Doctors' Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30850112
Citation
Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Heim L, Gombosev A, Avery TR, Haffenreffer K, Shimelman L, Hayden MK, Weinstein RA, Spencer-Smith C, Kaganov RE, Murphy MV, Forehand T, Lankiewicz J, Coady MH, Portillo L, Sarup-Patel J, Jernigan JA, Perlin JB, Platt R; ABATE Infection trial team. Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet. 2019 Mar 23;393(10177):1205-1215. doi: 10.1016/S0140-6736(18)32593-5. Epub 2019 Mar 5. Erratum In: Lancet. 2019 Mar 23;393(10177):1204. Lancet. 2019 Aug 10;394(10197):470.
Results Reference
derived
PubMed Identifier
26772801
Citation
Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.
Results Reference
derived

Learn more about this trial

Active Bathing to Eliminate Infection (ABATE Infection) Trial

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