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Mupirocin-Iodophor ICU Decolonization Swap Out Trial

NCT03140423 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 353323

Last updated 2025-03-30

Study results available
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Summary

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.

Conditions

  • Staphylococcus Aureus

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.

Sponsors & Collaborators

  • Hospital Corporation of America

    collaborator INDUSTRY

  • University of California, Irvine

    collaborator OTHER

  • University of Massachusetts, Amherst

    collaborator OTHER

  • Rush University

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • Harvard Pilgrim Health Care

    lead OTHER

Principal Investigators

  • Richard Platt, MD, MS · Harvard Pilgrim Health Care Institute

  • Susan Huang, MD, MPH · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2023-11-06
Completion
2023-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140423 on ClinicalTrials.gov