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Completed

NCT Number: NCT02063867

Active Bathing to Eliminate Infection (ABATE Infection) Trial

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.

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Key information

Conditions

Healthcare Associated Infections Cross Infection Disease Attributes Iatrogenic Disease Infections Methicillin Resistant Staphylococcus Aureus Multi Drug Resistant Organisms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Hills Hospital & Medical Center, West Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 2: Decolonization

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Other outcomes

  1. Urinary Tract Infections

    Time frame: 21 months

    Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge

  2. Blood Culture Contamination

    Time frame: 21 months

    Blood culture contamination

  3. Clostridium Difficile Infection

    Time frame: 21 months

    Clostridium difficile Infection attributable to participating units

  4. 30-Day Infectious Readmissions

    Time frame: 21 months

    30-Day Infectious Readmissions among patients in participating units

  5. Emergence of Resistance to Chlorhexidine or Mupirocin

    Time frame: 21 months

    Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units

  6. Cost Effectiveness

    Time frame: 21 months

    Cost effectiveness of routine care vs decolonization

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Cook County Health
  • Harvard Medical School (HMS and HSDM)
  • Harvard Pilgrim Health Care
  • Hospital Corporation of America
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
  • Rush University

Registry information

Official study 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)

Acronym: ABATE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2014
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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