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Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Non-inferiority cluster randomized controlled trial
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Completed
Sponsor
Harvard Pilgrim Health Care

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.