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Combination Treatment for Staph Infections (SHIELD Trial)

Whiteriver, AZ

Phase 4

Recruiting

Led By Laura Hammitt, MD

Research Sponsored by Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and older

Be older than 18 years old

Must not have

Allergy to citrus or any ingredient in Nozin, Hibiclens, or mupirocin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to find a way to reduce the spread of Staphylococcus aureus (SA) infections among Indigenous people. Participants will be divided into two groups - one group will receive education

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Who is the study for?

This trial is for Native American adults living near WMA Tribal lands, aged 18+, with lab-confirmed Staphylococcus aureus (SA) carriage. They must be able to consent and follow the study plan, and have either diabetes, a BMI ≥30, or past SA infections. Excluded are those who've taken antibiotics recently, currently have an SA infection, are related to the study staff, allergic to certain ingredients in the treatments or without a permanent home.Check my eligibility

What is being tested?

The trial aims to reduce skin SA carriage among participants using two methods: one group receives Mupirocin + Nozin + chlorhexidine gluconate; another gets education plus household supplies for prevention. The effectiveness of these approaches in reducing SA will be compared.See study design

What are the potential side effects?

Potential side effects may include skin reactions like irritation or allergy due to Mupirocin, Nozin nasal antiseptic or chlorhexidine gluconate used on the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to citrus, Nozin, Hibiclens, or mupirocin.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevalence of SA carriage

Secondary study objectives

Adverse events

Characterize SA isolates

Confirmed SA infection

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Education + Household supplies + Nasal antibiotic + Antiseptic regimenExperimental Treatment2 Interventions

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)

Group II: Education + Household suppliesActive Control1 Intervention

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

0 / 2Eligibility criteria met