NCT03140423

Mupirocin-Iodophor ICU Decolonization Swap Out Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 353,323 (actual)
• Sponsor: Harvard Pilgrim Health Care · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcus Aureus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-01
• Primary completion: 2023-11-06
• Completion: 2023-11-06
• First posted: 2017-05-04
• Last updated: 2025-03-30
• Results posted: 2024-02-07

Locations

137 sites across 1 country: United States

Regulatory

• FDA-regulated drug study