RECRUITING
I'm interested ...!!
Staph Intervention for Effective Local Defense
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.
Conditions:
🦠 Staphylococcus Aureus Infection
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 1 January 2026
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Whiteriver, Arizona, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 January 2024
  • First Submitted that Met QC Criteria 8 January 2024
  • First Posted 18 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 25 April 2024
  • Last Verified April 2024
I'm interested ...!!