Staph Intervention for Effective Local Defense (NCT06210594) | Clinical Trial Compass
CompletedPhase 4
Staph Intervention for Effective Local Defense
United States78 participantsStarted 2024-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of SA carriage
Timeframe: 4 months after randomization
Trial details
NCT IDNCT06210594
SponsorJohns Hopkins Bloomberg School of Public Health