Mupirocin-Iodophor ICU Decolonization Swap Out Trial | NCT03140423

Official Title

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 Module

Sponsor/Collaborators Module

Name	Class
Hospital Corporation of America	INDUSTRY
University of California, Irvine	OTHER
University of Massachusetts, Amherst	OTHER
Rush University

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Routine Care (Mupirocin/CHG)	Active Comparator	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)
Arm 2: Iodophor/CHG Decolonization	Active Comparator	ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing	Drug: Arm 2. Iodophor/CHG Decolonization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arm 1. Routine Care (Mupirocin/CHG)	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	18-month intervention

Secondary Outcomes

Measure	Description	Time Frame
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.	18-month intervention

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Richard Platt, MD, MS	Harvard Pilgrim Health Care Institute	Principal Investigator
Susan Huang, MD, MPH	University of California, Irvine	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Riverside Community Hospital		Riverside	California	92501	United States
Regional Medical Center of San Jose

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37815567	Result	Huang SS, Septimus EJ, Kleinman K, Heim LT, Moody JA, Avery TR, McLean L, Rashid S, Haffenreffer K, Shimelman L, Staub-Juergens W, Spencer-Smith C, Sljivo S, Rosen E, Poland RE, Coady MH, Lee CH, Blanchard EJ, Reddish K, Hayden MK, Weinstein RA, Carver B, Smith K, Hickok J, Lolans K, Khan N, Sturdevant SG, Reddy SC, Jernigan JA, Sands KE, Perlin JB, Platt R. Nasal Iodophor Antiseptic vs Nasal Mupirocin Antibiotic in the Setting of Chlorhexidine Bathing to Prevent Infections in Adult ICUs: A Randomized Clinical Trial. JAMA. 2023 Oct 10;330(14):1337-1347. doi: 10.1001/jama.2023.17219.

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 28, 2017	Dec 5, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Number of Participant totals reflect total Intervention participants. 137 hospitals were randomized to a study group, 69 began the assigned intervention. 1 hospital withdrew from the intervention arm and 2 hospitals withdrew from the control arm.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Overall number of participants reflect participants during the Intervention period.

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Age

- ParticipantsBG000168301
- ParticipantsBG001185022
- ParticipantsBG002353323

Title	Measurements

Sex/Gender, Customized

Proportion of female study participants during intervention study phase.

Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.

Count of Participants

Participants

Title	Denominators	Categories
Sex	ParticipantsBG000168219 ParticipantsBG001184950 ParticipantsBG002

Race/Ethnicity, Customized

Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.

Count of Participants

Participants

Title	Denominators	Categories
Race	ParticipantsBG000155666 ParticipantsBG001171982 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

The total number of participants analyzed reported here is from the intervention period.

Posted

Number

participants

18-month intervention

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000168301 OG001185022

Title

Denominators

Categories

Title	Measurements
	OG0002708 OG0013563

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.

The total number of participants analyzed reported here is from the intervention period.

Posted

Number

participants

18-month intervention

ID	Title	Description
OG000	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.
OG001	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.

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.

The total number of participants analyzed reported here is from the intervention period.

Posted

Number

participants

18-month intervention

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	168,301	0	168,301	0	168,301
EG001	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.	0	185,022	0	185,022	2	185,022

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Other (Not Including Serious) Adverse Event	Skin and subcutaneous tissue disorders		Systematic Assessment		EG0000 events0 affected168,301 at risk EG0012 events2 affected185,022 at risk

Certain Agreements

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013203	Staphylococcal Infections
D003428	Cross Infection