Clinical trial NCT02572791: Staph Household Intervention for Eradication (SHINE)
Official title: Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Staphylococcus Aureus
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 835
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of SSTI
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces
timeFrame: 9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months).
measure: Confirmed S. aureus Infection
timeFrame: 9 months
measure: Number of patients with adverse events due to study intervention
timeFrame: 3 months
measure: Mupirocin resistance
timeFrame: 9 months
measure: Number of participants adhering to study intervention procedures
timeFrame: 3 months
measure: Incidence of SSTI
timeFrame: 1 month, 6 months, and 9 months after randomization
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: St. 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: