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

This study is ongoing, but not recruiting participants.

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

NIH Common Fund

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Susan Huang, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT02063867

First received: February 12, 2014

Last updated: June 28, 2017

Last verified: June 2017

History of Changes

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: No masking 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


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

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

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	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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 )
Study First Received:	February 12, 2014
Last Updated:	June 28, 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

ClinicalTrials.gov processed this record on July 17, 2017

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