Individualized vs. Household MRSA Decolonization (HOME2DS)
Primary Purpose
Staphylococcal Skin Infection, Abscess, Furunculosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2% mupirocin ointment
Bleach Bath (dilute)
Hygiene Protocol
Sponsored by
About this trial
This is an interventional prevention trial for Staphylococcal Skin Infection focused on measuring Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infection, MRSA
Eligibility Criteria
Inclusion Criteria:
- 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."
Exclusion Criteria:
- Households in which all members experienced SSTI during the 12-month observational study
- Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Individualized Approach
Household Approach
Arm Description
The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
All members of the household will perform the decolonization regimen.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Participants With Incidence of SSTI at 1 Month After Decolonization
Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol
Number of Participants With Incidence of SSTI at 6 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol
Number of Participants With Incidence of SSTI at 9 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol
Number of Participants With Incidence of SSTI at 12 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol
Number of Participants Colonized With MRSA at 1 Month After Decolonization
Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit
Number of Participants Colonized With MRSA at 3 Months After Decolonization
Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit
Number of Participants Colonized With MRSA at 6 Months After Decolonization
Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit
Number of Participants Colonized With MRSA at 9 Months After Decolonization
Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit
Number of Participants Colonized With MRSA at 12 Months After Decolonization
Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol
Number of Participants Incurring Economic Burden of Performing Protocol
Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.
Number of Participants Adhering to Decolonization Measures
Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)
Full Information
NCT ID
NCT01814371
First Posted
March 15, 2013
Last Updated
February 4, 2019
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01814371
Brief Title
Individualized vs. Household MRSA Decolonization
Acronym
HOME2DS
Official Title
Individualized vs. Household Eradication of MRSA in Households With Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 26, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).
Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infection, Abscess, Furunculosis, Staphylococcus Aureus, MRSA Infection
Keywords
Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infection, MRSA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Individualized Approach
Arm Type
Active Comparator
Arm Description
The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Arm Title
Household Approach
Arm Type
Active Comparator
Arm Description
All members of the household will perform the decolonization regimen.
Intervention Type
Drug
Intervention Name(s)
2% mupirocin ointment
Other Intervention Name(s)
Bactroban
Intervention Description
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
Intervention Type
Other
Intervention Name(s)
Bleach Bath (dilute)
Other Intervention Name(s)
Clorox
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hygiene Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Incidence of SSTI at 3 Months After Decolonization
Description
Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol
Time Frame
3 months after enrollment
Secondary Outcome Measure Information:
Title
Number of Participants With Incidence of SSTI at 1 Month After Decolonization
Description
Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol
Time Frame
1 month after enrollment
Title
Number of Participants With Incidence of SSTI at 6 Months After Decolonization
Description
Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol
Time Frame
6 months after enrollment
Title
Number of Participants With Incidence of SSTI at 9 Months After Decolonization
Description
Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol
Time Frame
9 months after enrollment
Title
Number of Participants With Incidence of SSTI at 12 Months After Decolonization
Description
Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol
Time Frame
12 months after enrollment
Title
Number of Participants Colonized With MRSA at 1 Month After Decolonization
Description
Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit
Time Frame
1 month after enrollment
Title
Number of Participants Colonized With MRSA at 3 Months After Decolonization
Description
Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit
Time Frame
3 months after enrollment
Title
Number of Participants Colonized With MRSA at 6 Months After Decolonization
Description
Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit
Time Frame
6 months after enrollment
Title
Number of Participants Colonized With MRSA at 9 Months After Decolonization
Description
Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit
Time Frame
9 months after enrollment
Title
Number of Participants Colonized With MRSA at 12 Months After Decolonization
Description
Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit
Time Frame
12 months after enrollment
Title
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
Description
Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.
Time Frame
1 week after enrollment
Title
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
Description
Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol
Time Frame
1 month
Title
Number of Participants Incurring Economic Burden of Performing Protocol
Description
Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry
Time Frame
1 month after enrollment
Title
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
Description
Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.
Time Frame
1 Year
Title
Number of Participants Adhering to Decolonization Measures
Description
Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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."
Exclusion Criteria:
Households in which all members experienced SSTI during the 12-month observational study
Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Fritz, MD, MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32521007
Citation
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.
Results Reference
derived
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Individualized vs. Household MRSA Decolonization
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