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Mupirocin-Iodophor ICU Decolonization Swap Out Trial

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ClinicalTrials.gov Identifier: NCT03140423
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : February 16, 2021
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

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE May 4, 2017
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE May 1, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
ICU-attributable S. aureus clinical cultures (MRSA + MSSA) [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
ICU-attributable S. aureus clinical cultures (MRSA + MSSA) [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • 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.
  • ICU-attributable all-cause bloodstream infection [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • 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.
  • ICU-attributable all-cause bloodstream infection [ 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).
  • Mupirocin resistance in MRSA isolates [ Time Frame: 18-month intervention ]
    Mupirocin resistance as measured by minimum inhibitory concentration (MIC) among MRSA isolates from ICU patients between arms
  • Iodophor resistance in MRSA isolates [ Time Frame: 18-month intervention ]
    Iodophor resistance as measured by iodophor minimum inhibitory concentration (MIC) among MRSA isolates from ICU patients between arms
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2019)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mupirocin-Iodophor ICU Decolonization Swap Out Trial
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Non-inferiority cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcus Aureus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: Arm 1. Routine Care (Mupirocin/CHG)
  • 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
    Intervention: Drug: Arm 2. Iodophor/CHG Decolonization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 2, 2017)
137
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03140423
Other Study ID Numbers  ICMJE PH000599A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard Platt, Harvard Pilgrim Health Care
Study Sponsor  ICMJE Harvard Pilgrim Health Care
Collaborators  ICMJE
  • Hospital Corporation of America
  • University of California, Irvine
  • University of Massachusetts, Amherst
  • Rush University
  • Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Richard Platt, MD, MS Harvard Pilgrim Health Care Institute
Study Director: Susan Huang, MD, MPH University of California, Irvine
PRS Account Harvard Pilgrim Health Care
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP