Clinical trial NCT02063867: Active Bathing to Eliminate Infection (ABATE Infection) Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare Associated Infections
Methicillin Resistant Staphylococcus Aureus
Multi Drug Resistant Organisms
Keywords: HAI
MRSA
VRE
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Harvard Pilgrim Health Care
name: Hospital Corporation of America
name: Rush University
name: Cook County Health
name: Centers for Disease Control and Prevention
name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2014-02-14
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: MRSA and VRE Clinical Cultures
timeFrame: 21 months
Secondary outcomes:
measure: Gram-negative Multi-drug Resistant Organism Clinical Cultures
timeFrame: 21 months
measure: All-cause Bloodstream Infections
timeFrame: 21 months
Other outcomes:
measure: Urinary Tract Infections
timeFrame: 21 months
measure: Blood Culture Contamination
timeFrame: 21 months
measure: Clostridium Difficile Infection
timeFrame: 21 months
measure: 30-Day Infectious Readmissions
timeFrame: 21 months
measure: Emergence of Resistance to Chlorhexidine or Mupirocin
timeFrame: 21 months
measure: Cost Effectiveness
timeFrame: 21 months
Locations:
city: West Hills
country: United States
facility: West Hills Hospital & Medical Center
state: California
city: Thornton
country: United States
facility: North Suburban Medical Center
state: Colorado
city: Bradenton
country: United States
facility: Blake Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Loxahatchee Groves
country: United States
facility: Palms West Hospital
state: Florida
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
city: Pensacola
country: United States
facility: West Florida Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: St. Petersburg General Hospital
state: Florida
city: Sun City Center
country: United States
facility: South Bay Hospital
state: Florida
city: West Palm Beach
country: United States
facility: West Palm Hospital
state: Florida
city: Cartersville
country: United States
facility: Cartersville Medical Center
state: Georgia
city: Macon
country: United States
facility: Coliseum Northside Hospital
state: Georgia
city: Snellville
country: United States
facility: Eastside Medical Center
state: Georgia
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Lafayette
country: United States
facility: Regional Medical Center of Acadiana
state: Louisiana
city: Gulfport
country: United States
facility: Garden Park Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lee's Summit
country: United States
facility: Lee's Summit Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: MountainView Hospital-Las Vegas
state: Nevada
city: Derry
country: United States
facility: Parkland Medical Center
state: New Hampshire
city: Portsmouth
country: United States
facility: Portsmouth Regional Hospital
state: New Hampshire
city: Walterboro
country: United States
facility: Colleton Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge East Hospital
state: Tennessee
city: Dickson
country: United States
facility: TriStar Horizon Medical Center
state: Tennessee
city: Hendersonville
country: United States
facility: Hendersonville Medical Center
state: Tennessee
city: Hermitage
country: United States
facility: Summit Medical Center
state: Tennessee
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Brownsville
country: United States
facility: Valley Regional Medical Center
state: Texas
city: Conroe
country: United States
facility: Conroe Regional Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Medical Center
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Irving
country: United States
facility: Las Colinas Medical Center
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Live Oak
country: United States
facility: Northeast Methodist Hospital
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Hospital
state: Texas
city: Plano
country: United States
facility: Medical Center of Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Specialty and Transplant Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Stone Oak Hospital
state: Texas
city: Webster
country: United States
facility: Clear Lake Regional Medical Center
state: Texas
city: Orem
country: United States
facility: Timpanogos Regional Hospital
state: Utah
city: Hopewell
country: United States
facility: John Randolph Medical Center
state: Virginia
city: Low Moor
country: United States
facility: LewisGale Hospital-Alleghany
state: Virginia
city: Reston
country: United States
facility: Reston Hospital Center
state: Virginia
city: Richmond
country: United States
facility: Chippenham Johnston Willis Medical Center
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital
state: Virginia
Study officials:
affiliation: University of California, Irvine
name: Susan Huang, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Amherst
name: Ken Kleinman, ScD
role: STUDY_DIRECTOR
affiliation: Hospital Corporation of America
name: Edward Septimus, MD
role: STUDY_DIRECTOR
affiliation: Hospital Corporation of America
name: Jason Hickok, MBA, RN
role: STUDY_DIRECTOR
affiliation: Hospital Corporation of America
name: Julia Moody, MS
role: STUDY_DIRECTOR
affiliation: Rush University
name: Mary Hayden, MD
role: STUDY_DIRECTOR
affiliation: John Stroger Hospital
name: Robert Weinstein, MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: John Jernigan, MD MS
role: STUDY_DIRECTOR
affiliation: Hospital Corporation of America
name: Jonathan Perlin, MD PhD
role: STUDY_DIRECTOR
affiliation: University of California, Irvine
name: Daniel Gillen, PhD
role: STUDY_DIRECTOR
affiliation: Harvard Pilgrim Health Care Institute
name: Grace Lee, MD MPH
role: STUDY_DIRECTOR
References:
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.
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.