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Active Bathing to Eliminate Infection (ABATE Infection) Trial (ABATE)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Irvine
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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02063867
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Locations
| 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
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):
| 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