Mupirocin-Iodophor ICU Decolonization Swap Out Trial

Harvard Pilgrim Health Care

Status and phase: Completed; Phase 4

Conditions: Staphylococcus Aureus

Treatments: Drug: Arm 1. Routine Care (Mupirocin/CHG); Drug: Arm 2. Iodophor/CHG Decolonization

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT03140423

PH000599A

Details and patient eligibility

About

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.

Enrollment: 353,323 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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353,323 participants in 2 patient groups

Arm 1: Routine Care (Mupirocin/CHG)

Active Comparator group

Description:

ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing

Treatment:

Drug: Arm 1. Routine Care (Mupirocin/CHG)

Arm 2: Iodophor/CHG Decolonization

Active Comparator group

Description:

ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing

Treatment:

Drug: Arm 2. Iodophor/CHG Decolonization