Clinical trial NCT01814371: Individualized vs. Household MRSA Decolonization
Official title: Individualized vs. Household Eradication of MRSA in Households With Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcal Skin Infection
Abscess
Furunculosis
Staphylococcus Aureus
MRSA Infection
Keywords: Abscesses
Furunculosis
Staphylococcus aureus colonization
Staphylococcal Skin Infection
MRSA
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 474
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Number of Participants With Incidence of SSTI at 3 Months After Decolonization
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Number of Participants With Incidence of SSTI at 1 Month After Decolonization
timeFrame: 1 month after enrollment
measure: Number of Participants With Incidence of SSTI at 6 Months After Decolonization
timeFrame: 6 months after enrollment
measure: Number of Participants With Incidence of SSTI at 9 Months After Decolonization
timeFrame: 9 months after enrollment
measure: Number of Participants With Incidence of SSTI at 12 Months After Decolonization
timeFrame: 12 months after enrollment
measure: Number of Participants Colonized With MRSA at 1 Month After Decolonization
timeFrame: 1 month after enrollment
measure: Number of Participants Colonized With MRSA at 3 Months After Decolonization
timeFrame: 3 months after enrollment
measure: Number of Participants Colonized With MRSA at 6 Months After Decolonization
timeFrame: 6 months after enrollment
measure: Number of Participants Colonized With MRSA at 9 Months After Decolonization
timeFrame: 9 months after enrollment
measure: Number of Participants Colonized With MRSA at 12 Months After Decolonization
timeFrame: 12 months after enrollment
measure: Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
timeFrame: 1 week after enrollment
measure: Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
timeFrame: 1 month
measure: Number of Participants Incurring Economic Burden of Performing Protocol
timeFrame: 1 month after enrollment
measure: Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
timeFrame: 1 Year
measure: Number of Participants Adhering to Decolonization Measures
timeFrame: 1 week
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephanie A Fritz, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
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.