Active Bathing to Eliminate Infection (ABATE Infection) Trial

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • MRSA and VRE Clinical Cultures
    • Time Frame: 21 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 Measures

  • Gram-negative Multi-drug Resistant Organism Clinical Cultures
    • Time Frame: 21 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: 21 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 bacterial and yeast pathogens. Skin commensals require two positive blood cultures.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Irvine
  • Collaborator
    • Harvard Medical School (HMS and HSDM)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Susan Huang, Associate Professor and Medical Director of Epidemiology and Infection Prevention – University of California, Irvine
  • Overall Official(s)
    • Susan Huang, MD MPH, Principal Investigator, University of California, Irvine
    • Ken Kleinman, ScD, Study Director, University of Massachusetts, Amherst
    • Edward Septimus, MD, Study Director, Hospital Corporation of America (HCA)
    • Jason Hickok, MBA, RN, Study Director, Hospital Corporation of America
    • Julia Moody, MS, Study Director, Hospital Corporation of America
    • Mary Hayden, MD, Study Director, Rush University
    • Robert Weinstein, MD, Study Director, John Stroger Hospital
    • John Jernigan, MD MS, Study Director, Centers for Disease Control and Prevention
    • Jonathan Perlin, MD PhD, Study Director, Hospital Corporation of America
    • Daniel Gillen, PhD, Study Director, University of California, Irvine
    • Grace Lee, MD MPH, Study Director, Harvard Pilgrim Health Care Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.