HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial

Abstract

Background: A household approach to decolonization decreases skin and soft tissue infection (SSTI) incidence, though this is burdensome and costly. As prior SSTI increases risk for SSTI, we hypothesized that the effectiveness of decolonization measures to prevent SSTI when targeted to household members with prior year SSTI would be noninferior to decolonizing all household members.

Methods: Upon completion of our 12-month observational Household Observation of Methicillin-resistant Staphylococcus aureus in the Environment (HOME) study, 102 households were enrolled in HOME2, a 12-month, randomized noninferiority trial. Pediatric index patients with community-associated methicillin-resistant Staphylococcus aureus (MRSA) SSTI, their household contacts, and pets were enrolled. Households were randomized 1:1 to the personalized (decolonization performed only by household members who experienced SSTI during the HOME study) or household (decolonization performed by all household members) approaches. The 5-day regimen included hygiene education, twice-daily intranasal mupirocin, and daily bleach-water baths. At 5 follow-up visits in participants' homes, swabs to detect S. aureus were collected from participants, environmental surfaces, and pets; incident SSTIs were ascertained.

Results: Noninferiority of the personalized approach was established for the primary outcome 3-month cumulative SSTI: 23 of 212 (10.8%) participants reported SSTI in household approach households, while 23 of 236 (9.7%) participants reported SSTI in personalized approach households (difference in proportions, -1.1% [95% confidence interval, -6.7% to 4.5%]). In multivariable analyses, prior year SSTI and baseline MRSA colonization were associated with cumulative SSTI.

Conclusions: The personalized approach was noninferior to the household approach in preventing SSTI. Future studies should interrogate longer durations of decolonization and/or decontamination of the household environment to reduce household MRSA burden.

Clinical trials registration: NCT01814371.

Keywords: bleach; decolonization; methicillin-resistant Staphylococcus aureus; mupirocin; skin and soft tissue infection.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Figures

Figure 1.

Consolidated Standards for Reporting Trials (CONSORT) flow diagram for the HOME2 decolonization trial, showing study participants with data available for analysis of cumulative skin and soft tissue infection at each time point. Abbreviations: HOME, Household Observation of Methicillin-Resistant Staphylococcus aureus in the Environment; LTFU, lost to follow-up; SSTI, skin and soft tissue infection.

Figure 2.

A, Cumulative skin and soft tissue infection (SSTI) self-reported by household members following decolonization intervention. Differences in cumulative SSTI over time between the personalized and household decolonization approaches were compared using Fisher exact test (P > .05 at each time point). Cumulative SSTI defined as 1 or more SSTIs reported between baseline sampling and each follow-up visit. B, Cox proportional-hazard regression analysis for SSTI for up to 1 year between household members assigned the household and personalized decolonization approaches, adjusting for baseline MRSA colonization status. Household members assigned the personalized approach were not more likely to report an SSTI than those assigned the household approach (adjusted hazard ratio [aHR], 1.0 [95% confidence interval {CI}, .6–1.5]). Household members who were MRSA-colonized at baseline sampling were more likely to report an SSTI than those not colonized with MRSA (aHR, 2.3 [95% CI, 1.5–3.5]).

Figure 3.

Longitudinal household member Staphylococcus aureus colonization. Percentage of household members colonized with S. aureus (blue) and methicillin-resistant S. aureus (MRSA; red) at 6 sampling intervals over 12 months. 5-day decolonization intervention (personalized approach, light shade; household approach, dark shade) occurred immediately following baseline sampling. S. aureus includes MRSA and/or methicillin-susceptible S. aureus. Statistically significant changes in colonization at longitudinal samplings compared to baseline sampling within the decolonization approach represented by asterisks (using McNemar test: *P < .05, **P ≤ .01, ***P ≤ .001). Change in colonization between decolonization approaches was compared using Fisher exact test: for S. aureus, P = .01, P = .04, and P = .003 at 1-, 3-, and 12-month samplings, respectively; for MRSA: P > .05 at all samplings.