Individualized vs. Household MRSA Decolonization

Not Applicable

Completed

• Conditions: Abscess; Furunculosis; Staphylococcus Aureus; Staphylococcal Skin Infection; MRSA Infection
• Interventions: Drug: 2% mupirocin ointment; Other: Bleach Bath (dilute); Behavioral: Hygiene Protocol

• Registration Number: NCT01814371
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Study Start: 2013-04
• Primary Completion: 2017-02-26
• Study Completion: 2017-11-28
• Results First Submitted: 2018-04-09
• Results First Submitted QC: 2018-09-25
• Results First Posted: 2018-10-26
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-04
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

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."

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized Approach	2% mupirocin ointment	The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Individualized Approach	Bleach Bath (dilute)	The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Individualized Approach	Hygiene Protocol	The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.
Household Approach	Bleach Bath (dilute)	All members of the household will perform the decolonization regimen.
Household Approach	Hygiene Protocol	All members of the household will perform the decolonization regimen.
Household Approach	2% mupirocin ointment	All members of the household will perform the decolonization regimen.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of SSTI at 3 Months After Decolonization	3 months after enrollment	Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Incidence of SSTI at 9 Months After Decolonization	9 months after enrollment	Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol
Number of Participants Colonized With MRSA at 6 Months After Decolonization	6 months after enrollment	Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit
Number of Participants Colonized With MRSA at 3 Months After Decolonization	3 months after enrollment	Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit
Number of Participants Colonized With MRSA at 12 Months After Decolonization	12 months after enrollment	Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit
Number of Participants With Incidence of SSTI at 12 Months After Decolonization	12 months after enrollment	Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.	1 Year	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 Colonized With MRSA at 1 Month After Decolonization	1 month after enrollment	Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit
Number of Participants Colonized With MRSA at 9 Months After Decolonization	9 months after enrollment	Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance	1 month	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 Adhering to Decolonization Measures	1 week	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)
Number of Participants With Incidence of SSTI at 1 Month After Decolonization	1 month after enrollment	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	6 months after enrollment	Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period	1 week after enrollment	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 Participants Incurring Economic Burden of Performing Protocol	1 month after enrollment	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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States