UH3 Project: Active Bathing to Eliminate (ABATE) Infection
Overview
Principal Investigator:
Sponsoring Institution: University of California, Irvine
Collaborators:
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Hospital Corporation of America
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Harvard Medical School/Harvard Pilgrim Health Care
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University of California, Irvine, School of Medicine
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Rush University
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John H. Stroger Hospital
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Centers for Disease Control and Prevention
NIH Institute Providing Oversight: National Institute of Allergy and Infectious Diseases (NIAID)
Program Official: Clayton Huntley, PhD (NIAID)
Project Scientist: Gregory Deye, MD (NIAID)
ClinicalTrials.gov Identifier: NCT02063867
Study Locations: 53 locations across the United States
Trial Status: Completed
Trial Summary
Study question and significance: Universal antiseptic bathing and nasal decolonization are known to reduce bloodstream infections and multidrug-resistant organisms in intensive care unit (ICU) settings. However, the effects of this type of decolonization outside the ICU are unknown. The objective of ABATE Infection was to evaluate the use of universal chlorhexidine bathing plus targeted nasal decolonization for methicillin-resistant Staphylococcus aureus (MRSA) carriers in hospitalized patients outside the ICU.
Design and setting: Cluster randomized trial in 53 hospitals with 194 non–critical care units, of which 26 hospitals (with 90 non–critical care units) were randomly assigned to routine care and 27 hospitals (with 104 non–critical care units) were randomly assigned to the intervention.
Intervention and methods: The intervention included daily chlorhexidine bathing for all patients in the unit plus nasal mupirocin for known MRSA carriers. The primary outcome was MRSA or vancomycin-resistant enterococcus (VRE) clinical cultures attributed to participating units. The primary analysis was an unadjusted intention-to-treat analysis using proportional hazards models that accounted for clustering within hospitals. The analysis assessed whether the hazard ratio between the intervention and baseline periods differed significantly between study groups. Clinical cultures of multidrug-resistant, gram-negative bacteria and all-cause bloodstream infection were also evaluated as secondary outcomes.
Findings: Universal decolonization did not reduce multidrug-resistant bacteria or bloodstream infection in the overall non-ICU population. In a post hoc analysis of patients with medical devices, decolonization was associated with a significant 32% reduction in all-cause bloodstream infections and a significant 37% reduction in MRSA or vancomycin-resistant enterococcus clinical cultures attributable to participating units. Targeting patients with devices may be particularly valuable because they represented 10% of the non-ICU population but were responsible for 37% of all MRSA and VRE clinical cultures and 56% of all bloodstream infections in non-ICU patients.
Conclusions and relevance: Universal decolonization and targeted nasal decolonization did not significantly reduce the risk of multidrug-resistant infections in the overall non–critically ill patient population, but large reductions were seen in the subset of patients with medical devices.
Data and Resource Sharing
- ABATE_Closeout_Data and Resource Sharing Checklist Sept 2019
ABATE Closeout Data and Resource Sharing Checklist
- ABATE_MRSA_and_VRE_Specimen_to_share
ABATE Computable Phenotypes
- ABATE - Decolonization Protocol - 2-14-19 FINAL
ABATE Decolonization Protocol (Arm 2)
- ABATE - Routine Care Protocol - 2-14-19 FINAL
ABATE Routine Care Protocol (Arm 1)
- ABATE Data Request Form_2-21-2019
ABATE Data Request Form
- ABATE_Huang_UH3 follow-up
ABATE Ethics and Regulatory Documentation - UH3 Project Updates
Featured Interviews
Drs. Huang and Septimus discuss the ABATE Infection pragmatic clinical trial.
News and Interviews
- News_Your Pragmatic Trial Has Ended Now What
January 22, 2024: Your Pragmatic Trial Has Ended. Now What?
- News_AHRQ Publishes ABATE Infection Toolkit
March 22, 2022: AHRQ Publishes Hospital Infection Prevention Toolkit Based on ABATE Infection Trial
- Designing With Implementation in Mind
Designing With Implementation in Mind (Living Textbook Video Module)
- News_Collaboratory’s Susan Huang receives research achievement award from Clinical Research Forum
January 1, 2014: Collaboratory’s Susan Huang receives research achievement award from Clinical Research Forum
- News_Applying PRECIS Ratings to Collaboratory Pragmatic Trials
January 16, 2016: Applying PRECIS Ratings to Collaboratory Pragmatic Trials
- News_Collaboratory PIs Give Advice to New Pragmatic Trials
November 1, 2019: Collaboratory PIs Give Advice to New Pragmatic Trials
- News_PIs of Completed NIH Collaboratory Demonstration Projects Share Accomplishments
July 14, 2020: PIs of Completed NIH Collaboratory Trials Share Accomplishments
- News_Results of the Active Bathing to Eliminate (ABATE) Infection Trial Published in The Lancet
March 6, 2018: Results of the Active Bathing to Eliminate (ABATE) Infection Trial Published in The Lancet
- News_In New Video, Drs. Susan Huang and Gloria Coronado
February 7, 2018: In New Video, Drs. Susan Huang and Gloria Coronado Give Advice to Pragmatic Trial Investigators
- Susan-Huang
Video Interview: Interview with Dr. Susan Huang
Publications
- Sturdevant et al Contemp Clin Trials 2022
Matching in cluster randomized trials using the Goldilocks Approach
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- ABATE Infection Study Snapshot
ABATE Infection Study Snapshot
- Huang et al Lancet 2019
ABATE Infection Main Outcome Paper
- Living Textbook Chapter_Data Sharing Concerns
Living Textbook: Data Sharing Concerns
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- Living Textbook Chapter_Creation of Targeted Tools
Living Textbook Chapter Case Study: Dissemination and Implementation_Creation of Targeted Tools
- Kleinman and Huang EGEMS 2017
Calculating power by bootstrap, with an application to cluster-randomized trials
Presentations
- 2023 NIH Workshop_Panel 2_Sands_Septimus
2023 NIH Workshop Panel 2: Sands, Septimus
- 2023 NIH Workshop_Panel 1_Huang_Sands_Septimus
2023 NIH Workshop Panel 1: Huang, Sands, Septimus
- SC-2019-Completed-ABATE
Active Bathing to Eliminate (ABATE) Infection 2019 SC Meeting Presentation
- Presentation_ABATE_TiME_PROVEN_ARM_2019_c
Pragmatic Trial Design Panel (AcademyHealth 2019)
- Workshop Design and Analysis of PCT_Panel 1_Measurement and Data_Outcomes, Exposures, and Subgroups Based on EHR Data
Workshop Design and Analysis of PCT_Panel 1_Measurement and Data_Outcomes, Exposures, and Subgroups Based on EHR Data
- A vs B workshop_Panel 2_Examples in Action_Embedded A vs. B Trials
A vs B Workshop: Panel 2: Examples in Action
- 10.-Huang_ABATE-2018-UpdateFINAL_-Revised
ABATE Infection Trial Barriers and Lessons Learned Presentation at the 2018 SC meeting
- GR-Video-11-03-17
Results from the ABATE Infection Trial (GR Video 2017)
- GR-Slides-11-03-17
Results from the ABATE Infection Trial (GR Slides 2017)
- Panel 1 Setting the Stage for Dissemination and Implementation
Dissemination and Implementation Workshop Panel 1: Setting the Stage for Dissemination and Implementation
- Huang-SC-May-2017
ABATE Infection Trial Barriers and Lessons Learned 2017 SC Meeting Presentation
- GR-Video-04-28-17
Perspective on the Boundary between Quality Improvement Studies and Research: Patients, QI Leaders, IRB Leaders (GR Video 2017)
- GR-Slides-04-28-17
Perspective on the Boundary between Quality Improvement Studies and Research: Patients, QI Leaders, IRB Leaders (GR Slides 2017)
- GR-Video-05-13-16
ABATE Backstage Tour Coaching Call (GR Video 2016)
- GR-Slides-05-13-16
ABATE Backstage Tour Coaching Call (GR Slides 2016)
- Workshop_Ethical and Regulatory Issues of PCTs_Vulnerable Populations
Workshop: Ethical and Regulatory Issues of PCTs: Vulnerable Populations
- ABATE Infection Project - Barriers and Lessons Learned for Posting
ABATE: Generalizable Lessons Learned Presentation at 2016 SC Meeting
- ABATE Infection Project - Data Sharing
ABATE: Data Governance and Data Sharing Presentation at 2016 SC Meeting
- ABATE_Huang_04-21-15
ABATE UH3 Update at 2015 SC Meeting
- GR-Video-10-24-14
ABATE Infection Project (GR Video 2014)
- GR Slides 10-24-14
ABATE Infection Project (GR Slides 2014)
- ABATE Collaboratory UH3 Data_Resource Sharing_Kleinman_2-24-2014
ABATE UH3 - Data Sets and Data Sharing Presentation at the SC Meeting in 2014
- ABATE Collaboratory UH2_Lessons Learned_Septimus_2-25-2014
ABATE Collaboratory UH2 Lessons Learned 2014 SC Meeting Presentation
- ABATE Infection Project Ethics Supplement_Lankiewicz_2-24-2014
Ethics Supplement Program Update: Survey to Assess the Ethical Framework of Minimal-Risk Studies (ABATE)
- GR-Video-01-24-14
Survey to Assess Ethical Frameworks of Minimal Risk Studies (GR Video 2014)
- GR Slides 01-24-14
Survey to Assess Ethical Frameworks of Minimal Risk Studies (GR Slides 2014)
- GR-Video-08-16-13
The REDUCE MRSA Trial (GR Video 2013)
- GR Slides 08-16-13
The REDUCE MRSA Trial (GR Slides 2013)
- GR-Video-05-03-13
The HCA Journey (GR Video 2013)
- GR Slides 05-03-13
The HCA Journey (GR Slides 2013)