Individualized vs. Household MRSA Decolonization (HOME2DS)

The Washington University

Status: Completed

Conditions: Staphylococcal Skin Infection; MRSA Infection; Furunculosis; Staphylococcus Aureus; Abscess

Treatments: Other: Bleach Bath (dilute); Drug: 2% mupirocin ointment; Behavioral: Hygiene Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01814371

R01HS021736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 474 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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474 participants in 2 patient groups

Individualized Approach

Active Comparator group

Description:

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

Treatment:

Drug: 2% mupirocin ointment

Other: Bleach Bath (dilute)

Behavioral: Hygiene Protocol

Household Approach

Active Comparator group

Description:

All members of the household will perform the decolonization regimen.

Treatment:

Drug: 2% mupirocin ointment

Other: Bleach Bath (dilute)

Behavioral: Hygiene Protocol