Staph Household Intervention for Eradication (SHINE)

Washington University School of Medicine835 enrolled

Overview

The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces. The central hypothesis of this proposal is that an integrated approach of periodic personal and household environmental hygiene will reduce S. aureus transmission in households and subsequently decrease the incidence of skin and soft tissue infections (SSTI).

Patients with active or recent S. aureus SSTI will be recruited from St. Louis Children's Hospital and community pediatric practices affiliated with the investigators practice-based research network. All participants (index patients and their household contacts) will perform a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization regimen, households will be randomized to one of three intervention groups: 1) Periodic personal decolonization performed by all household members, to include chlorhexidine body washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated periodic personal decolonization and household environmental hygiene for 3 months. Households will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the prevalence of S. aureus colonization in the participants, household environmental surfaces, and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain typing will be performed on all recovered S. aureus isolates to illuminate transmission dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the investigators will assess resistance to the prescribed topical antimicrobials at baseline and longitudinal samplings.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients 18 years of age and younger * Confirmed (i.e., culture-positive) active or recent (within the past 2 months) S. aureus cutaneous infections * Reside within 75 miles of St. Louis Children's Hospital * Provide written, informed consent, or consent is provided by a parent or legal guardian Exclusion Criteria: * Patients with nosocomial infections (i.e., \>48 hours after hospitalization) * Patients with traditional risk factors for HA-MRSA (e.g., immunodeficiency, indwelling catheter or percutaneous medical device, undergoing dialysis, presenting with a surgical site infection, or residing in a long-term care facility within the past year). * Patients who are unable to give consent or for whom consent is not obtained * Patients refusing home environmental cultures by the study team * Patients without a permanent home (e.g., living in a shelter or group home)

Outcomes

Primary Outcomes

Incidence of SSTI

We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 3 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.

Time frame: 3 months after randomization

Secondary Outcomes

Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces

Describe baseline and longitudinal prevalence of MRSA colonization in index patients, household contacts, pet dogs and cats, and household surfaces and compare between the 3 intervention groups.

Time frame: 9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months).

Confirmed S. aureus Infection

We will compare the development of a confirmed S. aureus infection between participants in the 3 groups over 9 months at the household and individual level.

Time frame: 9 months

Number of patients with adverse events due to study intervention

We will describe the number of participants with adverse events due to study intervention (e.g., rhinorrhea, rash, dry skin) and compare between the three groups.

Time frame: 3 months

Mupirocin resistance

Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.

Time frame: 9 months

Number of participants adhering to study intervention procedures

We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures.

Time frame: 3 months

Incidence of SSTI

We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 1 month, 6 months, and 9 months after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups. In addition to to the household level, we will also assess SSTI outcomes at the individual household member level, the index patient level, and the household contact level.

Time frame: 1 month, 6 months, and 9 months after randomization

Staph Household Intervention for Eradication (SHINE)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes