Staphylococcus Aureus
Conditions
Keywords
MRSA, healthcare-associated infections, mupirocin, iodophor, resistance
Brief 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.
Interventions
DRUGArm 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.
DRUGArm 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.
Sponsors
Hospital Corporation of America
University of California, Irvine
University of Massachusetts, Amherst
Rush University
Centers for Disease Control and Prevention
Harvard Pilgrim Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Non-inferiority cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures | 18-month intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ICU Attributable MRSA Clinical Cultures | 18-month intervention | 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. |
| Number of Participants With ICU-attributable Bloodstream Infections | 18-month intervention | 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. |
Countries
United States
Participant flow
Recruitment details
137 out of 178 HCA Healthcare hospitals were recruited for this trial of adult ICUs. There was an 18-month intervention period from November 1, 2017 through April 30, 2019.
Pre-assignment details
353,323 patients were involved in the intervention period among adult ICUs from the 137 participating hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Routine Care (Mupirocin/CHG) ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
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. | 168,301 |
| Arm 2: Iodophor/CHG Decolonization ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
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. | 185,022 |
| Total | 353,323 |
Baseline characteristics
| Characteristic | Arm 1: Routine Care (Mupirocin/CHG) | Arm 2: Iodophor/CHG Decolonization | Total |
|---|---|---|---|
| Age, Continuous Age | 66.0 years | 66.0 years | 66.0 years |
| Race/Ethnicity, Customized Race Black or African American | 21901 Participants | 27776 Participants | 49677 Participants |
| Race/Ethnicity, Customized Race Other | 7016 Participants | 9146 Participants | 16162 Participants |
| Race/Ethnicity, Customized Race White | 126749 Participants | 135060 Participants | 261809 Participants |
| Sex/Gender, Customized Sex Female | 78074 Participants | 85194 Participants | 163268 Participants |
| Sex/Gender, Customized Sex Male | 90145 Participants | 99756 Participants | 189901 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 168,301 | 0 / 185,022 |
| other Total, other adverse events | 0 / 168,301 | 2 / 185,022 |
| serious Total, serious adverse events | 0 / 168,301 | 0 / 185,022 |
Outcome results
Primary
Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
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.
Time frame: 18-month intervention
Population: The total number of participants analyzed reported here is from the intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Routine Care (Mupirocin/CHG) | Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures | 2708 participants |
| Arm 2: Iodophor/CHG Decolonization | Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures | 3563 participants |
Secondary
Number of Participants With ICU-attributable Bloodstream Infections
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.
Time frame: 18-month intervention
Population: The total number of participants analyzed reported here is from the intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Routine Care (Mupirocin/CHG) | Number of Participants With ICU-attributable Bloodstream Infections | 1766 participants |
| Arm 2: Iodophor/CHG Decolonization | Number of Participants With ICU-attributable Bloodstream Infections | 1956 participants |
Secondary
Number of Participants With 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.
Time frame: 18-month intervention
Population: The total number of participants analyzed reported here is from the intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Routine Care (Mupirocin/CHG) | Number of Participants With ICU Attributable MRSA Clinical Cultures | 1377 participants |
| Arm 2: Iodophor/CHG Decolonization | Number of Participants With ICU Attributable MRSA Clinical Cultures | 1682 participants |