Combination Treatment for Staph Infections

(SHIELD Trial)

Overseen By Monica Pilewskie, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins Bloomberg School of Public Health

Must not be taking: Antibiotics

Disqualifiers: Current SA infection, Homelessness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 4 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective method to reduce Staphylococcus aureus (SA) on the skin, which can cause infections. Researchers seek to determine if combining education and household supplies with a nasal antibiotic (mupirocin) and an antiseptic routine (chlorhexidine gluconate) is more effective than using education and supplies alone. The trial seeks Native American adults living on or near WMA Tribal lands who have been confirmed to carry SA and have a risk factor such as diabetes, a high body mass index, or a history of skin infections. As a Phase 4 trial, this research focuses on an FDA-approved treatment to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used antibiotics in the 30 days before the study starts.

What is the safety track record for these treatments?

Research shows that mupirocin, when used as a nasal ointment, is generally safe for treating infections caused by *Staphylococcus aureus*. The FDA has already approved it for similar uses, such as treating impetigo, a skin infection, indicating it is well-tolerated with a known safety record.

Studies have found that Nozin, an alcohol-based antiseptic, effectively reduces nasal bacteria. It lowers the risk of infections, including those caused by *Staphylococcus*. This product is considered safe and is commonly used in healthcare settings to reduce bacteria.

Research also supports the safety of chlorhexidine gluconate, a widely used antiseptic. It is used for washing and helps prevent infections. Its regular use in medical settings demonstrates it is well-tolerated and effective in reducing infection risks.

The combination of these treatments has been studied for safety, and each component is generally known to be safe. Existing evidence supports the safety of these treatments, reassuring participants in this trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for Staph infections because they incorporate a multi-faceted approach beyond standard care. The first treatment combines education with household supplies such as cleaning products and laundry detergent, aiming to reduce bacterial presence in the home environment. The second treatment goes a step further by adding a nasal antibiotic called mupirocin and an antiseptic regimen, including Nozin and chlorhexidine gluconate. This combination targets the infection directly while maintaining a sanitized environment, potentially reducing the need for long-term antibiotic use and minimizing resistance.

What evidence suggests that this trial's treatments could be effective for reducing Staphylococcus aureus carriage?

Research has shown that nasal mupirocin effectively reduces Staphylococcus aureus (SA) and its resistant strains. One study found that mupirocin outperformed other nasal antiseptics in treating these infections. In this trial, one arm includes a combination of mupirocin, Nozin nasal antiseptic, and chlorhexidine gluconate wash, which successfully eliminated SA over several months. These treatments together help lower the risk of SA infections by reducing bacteria on the skin and in the nose. Another arm will focus on education and household supplies without the additional nasal antibiotic and antiseptic regimen. ^{6 7 8 9 10}

Who Is on the Research Team?

Laura Hammitt, MD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have diabetes, a BMI of 30 or higher, or had a skin infection in the last 3 years.

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

Lab-confirmed SA carriage at time of enrollment

Exclusion Criteria

I haven't taken antibiotics in the last 30 days.

I currently have a Staphylococcus aureus infection.

Immediate family member of study staff

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive education and household supplies, with Group A also receiving a nasal antibiotic and antiseptic regimen

4 months

Visits at baseline, Day 14, Day 30, Day 60, Day 90, and Day 120

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine gluconate
• Education + Household supplies
• Mupirocin
• Nozin

Trial Overview 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.

How Is the Trial Designed?

Group I: Education + Household supplies + Nasal antibiotic + Antiseptic regimen Experimental Treatment 2 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 supplies Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

A pilot study in urban Dhaka showed that a shared handwashing intervention using a homemade soapy water solution was both acceptable and feasible, with 75% of participating compounds adopting the system.

While the soapy water dispenser was popular and effective in promoting handwashing, challenges included reluctance to prepare the solution for communal use and the need for a sustainable maintenance system to ensure ongoing public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Sharing a Soapy Water System for Handwashing in a Low-Income Urban Community in Dhaka, Bangladesh: A Qualitative Study. Sultana, F., Unicomb, LE., Nizame, FA., et al.[2019]

A comprehensive training package was created for community-based frontline health workers in South Sudan, focusing on maternal, newborn, and child health emergencies, based on a needs assessment involving 33 health workers and various health facilities.

The training includes a 'training of trainers' approach, pictorial checklists for emergency management, and essential equipment, aiming to enhance the skills of previously untrained and illiterate health workers in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a community-based maternal, newborn and child emergency training package in South Sudan. Fehling, M., Nelson, BD., Ahn, R., et al.[2018]

Antimicrobial resistance is a growing global issue affecting both hospitals and communities, highlighting the need for effective strategies to combat it, especially in community settings.

Educational initiatives targeting both healthcare providers and patients are essential to address antibiotic resistance, as there is a lack of new antibiotics available for community use and for treating resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based strategies to reduce antibiotic resistance: are they valid in the community setting? Tillotson, GS., Blondeau, JM., Carroll, J.[2019]

A combined education and monitoring program significantly improved the appropriate use of gentamicin in a community hospital, increasing valid treatment indications from 75% to 87% among 162 patients studied.

The program also led to a rise in the use of bacteriologic cultures before treatment (from 85% to 97%) and a shift towards less toxic antibiotics (from 36% to 75%), demonstrating that educational interventions can enhance antibiotic prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of monitoring the use of gentamicin in a community hospital. Gilbert, DN., Eubanks, NM., Jackson, JM.[2019]

The pilot intervention showed that encouraging families to create their own handwashing stations was feasible, with 39 out of 40 households successfully making their own stations using simple materials like buckets and soap.

The study found that integrating handwashing education with child feeding programs was effective, as most caregivers recalled key messages about handwashing and its importance in preventing food contamination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision versus promotion to develop a handwashing station: the effect on desired handwashing behavior. Biswas, D., Nizame, FA., Sanghvi, T., et al.[2018]

A one-on-one educational intervention with 40 drug sellers in Tanzania significantly improved their knowledge and prescribing practices for malaria treatment, with 90% of trained sellers prescribing the correct first-line anti-malarial compared to only 55% in control shops.

While the intervention showed promise in enhancing compliance and performance in drug dispensing, it highlighted the need for ongoing strategies and involvement from national policies to achieve lasting improvements in the private sector's practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the impact of educational intervention for improving management of malaria and other childhood illnesses in Kibaha District-Tanzania. Nsimba, SE.[2016]

An educational program in Kilifi District, Kenya, significantly improved the appropriate use of anti-malarial drugs for childhood fevers, increasing the proportion of adequately treated cases from 2% to 15% at a cost of $4.00 per additional appropriately treated case during the early implementation phase.

The program is projected to be highly cost-effective at a district level, with an estimated cost of only $0.84 per additional appropriately treated case, making it a viable option for improving malaria treatment access and quality in rural communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of improving malaria home management: shopkeeper training in rural Kenya. Goodman, CA., Mutemi, WM., Baya, EK., et al.[2022]

The CoMPLI model, a community-wide educational strategy implemented over 6 months, successfully reduced antibiotic claims by nearly 10% in a small Ontario community, indicating improved adherence to clinical guidelines.

Physicians involved in the study were 29% less likely to prescribe second-line antibiotics compared to their peers, demonstrating the effectiveness of the educational interventions in promoting appropriate antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study for appropriate anti-infective community therapy. Effect of a guideline-based strategy to optimize use of antibiotics. Stewart, J., Pilla, J., Dunn, L.[2018]

Antimicrobial stewardship programs (ASPs) are increasingly incorporating educational interventions, but these should not be used alone; they are most effective when combined with other strategies like audit and feedback to improve prescribing behaviors.

Current evidence suggests that while educational methods can positively influence prescribing, there is limited support for their effectiveness as standalone interventions, particularly outside of public health initiatives, highlighting the need for further research in diverse healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of education in antimicrobial stewardship. Satterfield, J., Miesner, AR., Percival, KM.[2021]

In a study involving nearly 4000 under-five children, behavior change communication (BCC) activities aimed at educating mothers were associated with a higher incidence of pneumonia (0.80 episodes per child per year) compared to the control group (0.48 episodes per child per year), indicating that the intervention did not effectively reduce pneumonia rates.

The findings suggest that while BCC activities were implemented, they alone were insufficient to lower the incidence of childhood pneumonia, highlighting the need for more comprehensive strategies beyond maternal education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Behavior Change Communication on the Incidence of Pneumonia in Under Five Children: A Cluster Randomized Controlled Trial. Gothankar, J., Pore, P., Dhumale, G., et al.[2021]

Citations

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Myths Glorify What Reality Neglects: Efficacy and Safety of ... This review critically examines the efficacy and safety of chlorhexidine gluconate (CHG), the gold-standard antiseptic for infection prevention.

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Strategies to Prevent Hospital-onset Staphylococcus ... Topical chlorhexidine gluconate (at least 2%) + Intranasal antistaphylococcal antibiotic/antiseptic (e.g. mupirocin or iodophor) (core strategy) ...

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Effect of chlorhexidine bathing in preventing infections and ... This review examines the evidence that chlorhexidine bathing can prevent colonization and infection with health care-associated pathogens and reduce ...

10. molnlycke.us molnlycke.us/products-solutions/hibiclens/

Hibiclens 4% chlorhexidine gluconate CHG surgical ... In large peer-reviewed studies, daily bathing with CHG showed significant reductions in infection rates. Washes clean, leaving a layer of CHG protection without ...