Phase 4
N=353,323
Mupirocin-Iodophor ICU Decolonization Swap Out Trial
Staphylococcus Aureus
Bottom Line
View on ClinicalTrials.gov: NCT03140423 ↗Enrolled (actual)
353,323
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures — 2708; 3563 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Arm 1. Routine Care (Mupirocin/CHG) (Drug); Arm 2. Iodophor/CHG Decolonization (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Harvard Pilgrim Health Care
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures |
2708; 3563 | — |
| SECONDARY Number of Participants With ICU Attributable MRSA Clinical Cultures |
1377; 1682 | — |
| SECONDARY Number of Participants With ICU-attributable Bloodstream Infections |
1766; 1956 | — |
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.
Eligibility 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 =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.
Data sourced from ClinicalTrials.gov (NCT03140423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.