Phase 4 N=833 Randomized Treatment

Staph Household Intervention for Eradication (SHINE)

Skin and Subcutaneous Tissue Bacterial Infections · Staphylococcus Aureus · MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Bottom Line

View on ClinicalTrials.gov: NCT02572791 ↗

Enrolled (actual)

833

Serious AEs

0.0%

Results posted

Feb 2026

Primary outcome: Primary: Number of Households With at Least One Skin and Soft Tissue Infection — 21; 21; 22 Households

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Chlorhexidine (Drug); Mupirocin (Drug); Household cleaning (Behavioral)
Age: Pediatric, Adult
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Nov 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Households With at Least One Skin and Soft Tissue Infection	21; 21; 22	—
SECONDARY Prevalence of MRSA Colonization in Participants	12; 22; 24	—
SECONDARY Prevalence of MRSA Colonization in Participants	12; 22; 24	—
SECONDARY Confirmed S. Aureus Infection	84; 71; 135	—
SECONDARY Incidence of SSTI	30; 32; 38	—
SECONDARY Incidence of SSTI	30; 32; 38	—
SECONDARY Incidence of SSTI	30; 32; 38	—
SECONDARY Mupirocin Resistance	6; 1; 2	—
SECONDARY Number of Patients With Adverse Events Due to Study Intervention	111; 92; 137	—
SECONDARY Number of Participants Adhering to Study Intervention Procedures	112; 45; 55	—
SECONDARY SSTI Incidence: Individual Level	39; 31; 43	—
SECONDARY SSTI Incidence: Individual Level	39; 31; 43	—
SECONDARY SSTI Incidence: Individual Level	39; 31; 43	—
SECONDARY SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	36; 40; 25	—
SECONDARY SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	36; 40; 25	—
SECONDARY SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	36; 40; 25	—
SECONDARY SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment	36; 40; 25	—
SECONDARY SSTI Incidence: Index Patients	23; 27; 16	—
SECONDARY SSTI Incidence: Index Patients	23; 27; 16	—
SECONDARY SSTI Incidence: Index Patients	23; 27; 16	—
SECONDARY SSTI Incidence: Index Patients	23; 27; 16	—

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).

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02572791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.