Mupirocin-Iodophor ICU Decolonization Swap Out Trial

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Staphylococcus Aureus

Intervention / Treatment
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* Drug: Arm 1. Routine Care (Mupirocin/CHG)
* Drug: Arm 2. Iodophor/CHG Decolonization


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Routine Care (Mupirocin/CHG)<br>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)<br>* 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.<br>|
| Active Comparator: Arm 2: Iodophor/CHG Decolonization<br>ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing | Drug: Arm 2. Iodophor/CHG Decolonization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU-attributable S. aureus clinical cultures (MRSA + MSSA) | 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. | 18-month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18-month intervention | 
| ICU-attributable all-cause bloodstream infection | 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. | 18-month intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iodophor, healthcare-associated infections, mupirocin, resistance, MRSA