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Completed

NCT Number: NCT03140423

Mupirocin-Iodophor ICU Decolonization Swap Out Trial

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.

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Key information

Conditions

Staphylococcus Aureus Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Staphylococcal Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Riverside Community Hospital, Riverside, 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

  • 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.

Treatment and study plan

Arm 1. Routine Care (Mupirocin/CHG)

Drug

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.

Arm 2. Iodophor/CHG Decolonization

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Hospital Corporation of America
  • Rush University
  • University of California, Irvine
  • University of Massachusetts, Amherst

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 4, 2017
Registry last updated
Mar 30, 2025

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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