SHIELD (Staph Intervention for Effective Local Defense): An Open-label Randomized Controlled Trial to Assess Efficacy of a Sustained Intervention (Topical Antibiotics and Skin Antisepsis) to Decrease Staphylococcus Aureus Carriage in Adults

IRB00027090

Indigenous persons experience a high burden of Staphylococcus aureus (SA) invasive disease and skin and soft tissue infections. SA carriage on the skin is factor for development of SA infections. The goal of this clinical trial is to evaluate a community-informed approach to reduce carriage of SA. Participants will be assigned to education and household supplies for prevention of SA with and without a biomedical intervention. Researchers will compare SA carriage in the two groups.

2024-04-01

2025-01-01

2026-01-01

Recruiting

Early phase I

100

Inclusion Criteria: * Native American adult living on or adjacent to the WMA Tribal lands * 18 years of age and older * Lab-confirmed SA carriage at time of enrollment * Ability to provide written informed consent * Ability to comply with follow-up activities * Risk factor for SA-associated infection: Diagnosed with diabetes OR body mass index ≥30 OR documented SSTI or SA infection in the past 3 years Exclusion Criteria: * Immediate family member of study staff * Allergy to citrus or any ingredient in Nozin, Hibiclens, or mupirocin * Without a permanent home (e.g., living in a group home, shelter, or is unhoused) * Use of antibiotics within 30 days prior to the first study visit (time-limited) * Current SA infection (time-limited)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will be an open-label randomized controlled trial to determine the feasibility, acceptability, and efficacy of a carriage suppression regimen in reducing the prevalence of SA carriage and SA infections among adults at high risk of SA infections who are currently carrying SA in the oropharynx or anterior nares. Participants will be randomized in a ratio of 1:1 to either:\n\n1. education about SA and receipt of household supplies to reduce SA transmission in the home plus use of a nasal antibiotic twice daily for 5 days then maintenance with an antiseptic regimen (N=50; intervention group);\n\n or\n2. education/household supplies alone (N = 50; control group).\n\nAll participants will be followed for 4 months.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-25