Individualized vs. Household MRSA Decolonization
HOME2DS
Individualized vs. Household Eradication of MRSA in Households With Children
1 other identifier
interventional
474
1 country
1
Brief Summary
The purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent Staphylococcus aureus skin infections. The investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent SSTI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
March 19, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2017
CompletedResults Posted
Study results publicly available
October 26, 2018
CompletedFebruary 21, 2019
February 1, 2019
3.9 years
March 15, 2013
April 9, 2018
February 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Incidence of SSTI at 3 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol
3 months after enrollment
Secondary Outcomes (14)
Number of Participants With Incidence of SSTI at 1 Month After Decolonization
1 month after enrollment
Number of Participants With Incidence of SSTI at 6 Months After Decolonization
6 months after enrollment
Number of Participants With Incidence of SSTI at 9 Months After Decolonization
9 months after enrollment
Number of Participants With Incidence of SSTI at 12 Months After Decolonization
12 months after enrollment
Number of Participants Colonized With MRSA at 1 Month After Decolonization
1 month after enrollment
- +9 more secondary outcomes
Study Arms (2)
Individualized Approach
ACTIVE COMPARATORThe decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Household Approach
ACTIVE COMPARATORAll members of the household will perform the decolonization regimen.
Interventions
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.
Follow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share.
Eligibility Criteria
You may qualify if:
- Individuals who are enrolled in a 12-month observational study entitled "The Community-Associated Methicillin-Resistant Staphylococcus aureus Among Household Members and the Home Environment Study."
You may not qualify if:
- Households in which all members experienced SSTI during the 12-month observational study
- Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (1)
Hogan PG, Parrish KL, Mork RL, Boyle MG, Muenks CE, Thompson RM, Morelli JJ, Sullivan ML, Hunstad DA, Bubeck Wardenburg J, Rzhetsky A, Gehlert SJ, Burnham CD, Fritz SA. HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4568-e4577. doi: 10.1093/cid/ciaa752.
PMID: 32521007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Fritz, MD, MSCI
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie A Fritz, MD, MSCI
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
March 15, 2013
First Posted
March 19, 2013
Study Start
April 1, 2013
Primary Completion
February 26, 2017
Study Completion
November 28, 2017
Last Updated
February 21, 2019
Results First Posted
October 26, 2018
Record last verified: 2019-02