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Education + Household supplies + Nasal antibiotic + Antiseptic regimen for Staph Infection (SHIELD Trial)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

SHIELD 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

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.

SHIELD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

SHIELD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevalence of SA carriage

Secondary outcome measures

Adverse events

Characterize SA isolates

Confirmed SA infection

+4 more

SHIELD 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 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,012 Total Patients Enrolled

Johns Hopkins Bloomberg School of Public HealthLead Sponsor

410 Previous Clinical Trials

2,106,830 Total Patients Enrolled

Laura Hammitt, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

3 Previous Clinical Trials

997 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this research study?

"As per the information available on clinicaltrials.gov, this particular study is not currently seeking participants. The trial was posted on January 1st, 2024 and last updated on January 8th, 2024. However, it's worth noting that there are currently 16 other ongoing clinical trials actively accepting patients at this time."

Answered by AI

Has the combination of Education + Household supplies + Nasal antibiotic + Antiseptic regimen been granted official approval by the FDA?

"Given the approval of this treatment and its categorization as a Phase 4 trial, our team at Power rates the safety of Education + Household supplies + Nasal antibiotic + Antiseptic regimen with a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Staph Intervention for Effective Local Defense

2024. "Staph Intervention for Effective Local Defense". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06210594.