Staph Intervention for Effective Local Defense

NCT06210594 | Completed Phase 4 FDA Drug

• 2 other identifiers: IRB000270905S06GM142120
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Staphylococcus Aureus Infection

Keywords

Skin and soft tissue infections (SSTI); Methicillin-resistant staphylococcus aureus (MRSA); Carriage density; Biomedical intervention

Outcome Measures

Primary Outcomes (1)

• Prevalence of SA carriage

  Compare SA carriage prevalence in the nose, throat, and skin (any site) between arms.

  4 months after randomization

Secondary Outcomes (7)

• Feasibility and Acceptability

  4 months

• Feasibility and Acceptability as assessed by in depth interviews

  4 months

• Incidence of SSTI

  4 months

• Characterize SA isolates

  4 months

• Confirmed SA infection

  4 months

Study Arms (2)

Education + Household supplies + Nasal antibiotic + Antiseptic regimen

EXPERIMENTAL

Participants in this arm will receive education about SA and household supplies (e.g., cleaning products, pump lotion, laundry detergent, towels) plus use of a nasal antibiotic (mupirocin) twice daily for 5 days then maintenance with an antiseptic regimen (Nozin twice daily plus chlorhexidine gluconate wash 3 times per week)

Combination Product: Mupirocin + Nozin + chlorhexidine gluconate; Behavioral: Education + Household supplies

Education + Household supplies

ACTIVE COMPARATOR

Participants in this arm will receive education about SA and household supplies (e.g., cleaning products, pump lotion, laundry detergent, towels).

Behavioral: Education + Household supplies

Interventions

Mupirocin + Nozin + chlorhexidine gluconate COMBINATION_PRODUCT

Education/household supplies + antibiotic + antiseptic regimen

Also known as: Bactroban + Nozin + Hibiclens

Education + Household supplies + Nasal antibiotic + Antiseptic regimen

Education + Household supplies BEHAVIORAL

Education/household supplies

Education + Household supplies; Education + Household supplies + Nasal antibiotic + Antiseptic regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Native American adult living on or adjacent to the WMA Tribal lands
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Whiteriver Center for Indigenous Health

Whiteriver, Arizona, 85941, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Soft Tissue Infections

Interventions

Mupirocin; chlorhexidine gluconate; Educational Status; Household Products

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Socioeconomic Factors; Population Characteristics; Technology, Industry, and Agriculture

Study Officials

• Laura Hammitt, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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: 1. 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); or 2. education/household supplies alone (N = 50; control group). All participants will be followed for 4 months.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: April 1, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)