A Phase 4 interventional study of Arm 1. Routine Care (Mupirocin/CHG) and Arm 2. Iodophor/CHG Decolonization in Staphylococcus Aureus, sponsored by Harvard Pilgrim Health Care. Completed at 137 sites in United States. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Harvard Pilgrim Health Care · Phase 4, Interventional, and Prevention
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.
Harvard Pilgrim Health Care is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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 mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
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.
Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
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.
Time frame: 18-month intervention
Number of Participants With ICU Attributable MRSA Clinical Cultures
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.
Time frame: 18-month intervention
Number of Participants With ICU-attributable Bloodstream Infections
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.
Time frame: 18-month intervention
137 out of 178 HCA Healthcare hospitals were recruited for this trial of adult ICUs. There was an 18-month intervention period from November 1, 2017 through April 30, 2019.
| Milestone | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization |
|---|---|---|
| Started | 168301 | 185022 |
| Completed | 168301 | 185022 |
| Not completed | 0 | 0 |
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.
| participants | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization |
|---|---|---|
| Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures | 2708 | 3563 |
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.
| participants | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization |
|---|---|---|
| Number of Participants With ICU Attributable MRSA Clinical Cultures | 1377 | 1682 |
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.
| participants | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization |
|---|---|---|
| Number of Participants With ICU-attributable Bloodstream Infections | 1766 | 1956 |
Collected over 18 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Routine Care (Mupirocin/CHG) | 0/168,301 (0%) | 0/168,301 (0%) | 0/168,301 (0%) |
| Arm 2: Iodophor/CHG Decolonization | 0/185,022 (0%) | 0/185,022 (0%) | 2/185,022 (0%) |
| Event | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization |
|---|---|---|
| Other (Not Including Serious) Adverse EventSkin and subcutaneous tissue disorders | 0/168301 | 2/185022 |
Number of Participant totals reflect total Intervention participants. 137 hospitals were randomized to a study group, 69 began the assigned intervention. 1 hospital withdrew from the intervention arm and 2 hospitals withdrew from the control arm.
| Age, Continuous(years) | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization | Total |
|---|---|---|---|
| Age | 66.0 (54.0 to 76.0) | 66.0 (54.0 to 76.0) | 66.0 (53.0 to 76.0) |
| Sex/Gender, Customized(Participants) | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization | Total |
|---|---|---|---|
| Sex — Female | 78074 | 85194 | 163268 |
| Sex — Male | 90145 | 99756 | 189901 |
| Race/Ethnicity, Customized(Participants) | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization | Total |
|---|---|---|---|
| Race — Black or African American | 21901 | 27776 | 49677 |
| Race — White | 126749 | 135060 | 261809 |
| Race — Other | 7016 | 9146 | 16162 |
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