Active Bathing to Eliminate Infection (ABATE Infection) Trial

Healthcare Associated Infections Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063867
• Other study ID #: 367981
• Secondary ID: UH2AT007769UH3AI
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: February 2019

Study information

• Verified date: June 2019
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infections
• Infection
• Methicillin Resistant Staphylococcus Aureus
• Multi Drug Resistant Organisms
• Staphylococcal Infections

Intervention

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.

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas
United States	Blake Medical Center	Bradenton	Florida
United States	Valley Regional Medical Center	Brownsville	Texas
United States	Cartersville Medical Center	Cartersville	Georgia
United States	Parkridge East Hospital	Chattanooga	Tennessee
United States	Parkridge Medical Center	Chattanooga	Tennessee
United States	Conroe Regional Medical Center	Conroe	Texas
United States	Corpus Christi Medical Center	Corpus Christi	Texas
United States	Parkland Medical Center	Derry	New Hampshire
United States	TriStar Horizon Medical Center	Dickson	Tennessee
United States	Las Palmas Medical Center	El Paso	Texas
United States	Plaza Medical Center of Fort Worth	Fort Worth	Texas
United States	Garden Park Medical Center	Gulfport	Mississippi
United States	Hendersonville Medical Center	Hendersonville	Tennessee
United States	Summit Medical Center	Hermitage	Tennessee
United States	John Randolph Medical Center	Hopewell	Virginia
United States	Las Colinas Medical Center	Irving	Texas
United States	Research Medical Center	Kansas City	Missouri
United States	Kingwood Medical Center	Kingwood	Texas
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	Regional Medical Center of Acadiana	Lafayette	Louisiana
United States	MountainView Hospital-Las Vegas	Las Vegas	Nevada
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	Lee's Summit Medical Center	Lee's Summit	Missouri
United States	Northeast Methodist Hospital	Live Oak	Texas
United States	LewisGale Hospital-Alleghany	Low Moor	Virginia
United States	Palms West Hospital	Loxahatchee Groves	Florida
United States	Coliseum Northside Hospital	Macon	Georgia
United States	Rio Grande Regional Hospital	McAllen	Texas
United States	North Hills Hospital	North Richland Hills	Texas
United States	Orange Park Medical Center	Orange Park	Florida
United States	Timpanogos Regional Hospital	Orem	Utah
United States	Overland Park Regional Medical Center	Overland Park	Kansas
United States	West Florida Hospital	Pensacola	Florida
United States	Medical Center of Plano	Plano	Texas
United States	Portsmouth Regional Hospital	Portsmouth	New Hampshire
United States	Reston Hospital Center	Reston	Virginia
United States	Chippenham Johnston Willis Medical Center	Richmond	Virginia
United States	Henrico Doctors' Hospital	Richmond	Virginia
United States	Northside Hospital	Saint Petersburg	Florida
United States	St. Petersburg General Hospital	Saint Petersburg	Florida
United States	Methodist Hospital	San Antonio	Texas
United States	Methodist Specialty and Transplant Hospital	San Antonio	Texas
United States	Methodist Stone Oak Hospital	San Antonio	Texas
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	Eastside Medical Center	Snellville	Georgia
United States	South Bay Hospital	Sun City Center	Florida
United States	North Suburban Medical Center	Thornton	Colorado
United States	Colleton Medical Center	Walterboro	South Carolina
United States	Clear Lake Regional Medical Center	Webster	Texas
United States	West Hills Hospital & Medical Center	West Hills	California
United States	West Palm Hospital	West Palm Beach	Florida

Sponsors (9)

Lead Sponsor	Collaborator
University of California, Irvine	Centers for Disease Control and Prevention, Harvard Medical School, Harvard Pilgrim Health Care, Hospital Corporation of America (HCA), John H. Stroger Hospital, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Rush University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary Tract Infections	Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge	21 months
Other	Blood Culture Contamination	Blood culture contamination	21 months
Other	Clostridium Difficile Infection	Clostridium difficile Infection attributable to participating units	21 months
Other	30-Day Infectious Readmissions	30-Day Infectious Readmissions among patients in participating units	21 months
Other	Emergence of Resistance to Chlorhexidine or Mupirocin	Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units	21 months
Other	Cost Effectiveness	Cost effectiveness of routine care vs decolonization	21 months
Primary	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	21 months
Secondary	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	21 months
Secondary	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.	21 months