Mupirocin-Iodophor ICU Decolonization Swap Out Trial

Overview

The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens: Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing ~235 ICUs) that have been randomized.

Full Title of Study: “Cluster-randomized Non-inferiority Trial Comparing Mupirocin vs Iodophor for Nasal Decolonization of ICU Patients to Assess Impact on S. Aureus Clinical Cultures and All-cause Bloodstream Infection During Routine Chlorhexidine Bathing”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 6, 2023

Interventions

  • Drug: Arm 1. Routine Care (Mupirocin/CHG)
    • The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
  • Drug: Arm 2. Iodophor/CHG Decolonization
    • The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.

Arms, Groups and Cohorts

  • Active Comparator: Arm 1: Routine Care (Mupirocin/CHG)
    • ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
  • Active Comparator: Arm 2: Iodophor/CHG Decolonization
    • ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
    • Time Frame: 18-month intervention
    • Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring >2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.

Secondary Measures

  • Number of Participants With ICU Attributable MRSA Clinical Cultures
    • Time Frame: 18-month intervention
    • Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating ICUs. Defined as occurring >2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
  • Number of Participants With ICU-attributable Bloodstream Infections
    • Time Frame: 18-month intervention
    • All-cause bloodstream infection attributable to participating ICUs. Defined as occurring >2 days into a participating ICU stay through 2 days following ICU discharge.Includes subsets of gram positive (GP), gram negative (GN) and fungal (candida) bloodstream infections, as well as key pathogens such as S. aureus (MRSA and MSSA). NOTE: this outcome is intended for the primary manuscript.

Participating in This Clinical Trial

Inclusion Criteria

Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;

  • Note: Unit of randomization is the hospital, but the participants are hospital adult ICUs – All patients within adult ICUs are included, including rare patients <18 years and >=12 years. Exclusion Criteria:

Exclusion criteria includes ICUs with an average length of stay of less than 2 days;

  • HCA hospitals that are not able to transfer or merge data into the centralized data warehouse for the baseline and intervention periods of the study are also excluded.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Harvard Pilgrim Health Care
  • Collaborator
    • Hospital Corporation of America
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard Platt, Professor and Department Chair – Harvard Pilgrim Health Care
  • Overall Official(s)
    • Richard Platt, MD, MS, Principal Investigator, Harvard Pilgrim Health Care Institute
    • Susan Huang, MD, MPH, Study Director, University of California, Irvine

Citations Reporting on Results

Huang SS, Septimus EJ, Kleinman K, Heim LT, Moody JA, Avery TR, McLean L, Rashid S, Haffenreffer K, Shimelman L, Staub-Juergens W, Spencer-Smith C, Sljivo S, Rosen E, Poland RE, Coady MH, Lee CH, Blanchard EJ, Reddish K, Hayden MK, Weinstein RA, Carver B, Smith K, Hickok J, Lolans K, Khan N, Sturdevant SG, Reddy SC, Jernigan JA, Sands KE, Perlin JB, Platt R. Nasal Iodophor Antiseptic vs Nasal Mupirocin Antibiotic in the Setting of Chlorhexidine Bathing to Prevent Infections in Adult ICUs: A Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1337-1347. doi: 10.1001/jama.2023.17219.

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