Mupirocin-Iodophor ICU Decolonization Swap Out Trial

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harvard Pilgrim Health Care
• Collaborators: Centers for Disease Control and Prevention; Hospital Corporation of America; Rush University; University of California, Irvine; University of Massachusetts, Amherst
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Mupirocin

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 <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.