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Mupirocin-Iodophor ICU Decolonization Swap Out Trial

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ClinicalTrials.gov Identifier: NCT03140423
Recruitment Status : Completed
First Posted : May 4, 2017
Results First Posted : February 7, 2024
Last Update Posted : February 7, 2024
Sponsor:
Collaborators:
Hospital Corporation of America
University of California, Irvine
University of Massachusetts, Amherst
Rush University
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Drug: Arm 1. Routine Care (Mupirocin/CHG) Drug: Arm 2. Iodophor/CHG Decolonization Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 353323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : November 6, 2023
Actual Study Completion Date : November 6, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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.
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Mupirocin & Iodophor Resistance in MRSA Isolates [ Time Frame: 18-month intervention ]
    Mupirocin and iodophor resistance as measured by minimum inhibitory concentration (MIC) among MRSA isolates from ICU patients between arms. NOTE: this outcome is intended for a secondary manuscript.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140423


Locations
Show Show 137 study locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
Hospital Corporation of America
University of California, Irvine
University of Massachusetts, Amherst
Rush University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Richard Platt, MD, MS Harvard Pilgrim Health Care Institute
Study Director: Susan Huang, MD, MPH University of California, Irvine
  Study Documents (Full-Text)

Documents provided by Richard Platt, Harvard Pilgrim Health Care:
Study Protocol  [PDF] April 28, 2017
Statistical Analysis Plan  [PDF] August 14, 2019

More Information
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Additional Information:

Publications of Results:

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Responsible Party: Richard Platt, Professor and Department Chair, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT03140423    
Other Study ID Numbers: PH000599A
First Posted: May 4, 2017    Key Record Dates
Results First Posted: February 7, 2024
Last Update Posted: February 7, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
MRSA
healthcare-associated infections
mupirocin
iodophor
resistance
Additional relevant MeSH terms:
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Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action