Nasal Antiseptic for Fungal Infections

Recruiting at 2 trial locations

Overseen By Mary K. Hayden, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mary K Hayden

Disqualifiers: Severe iodine allergy, Pregnant, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 1 week

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a nasal antiseptic, specifically 10% povidone iodine, against a fungal infection caused by Candida auris. Participants will either receive routine care or have the antiseptic applied in their nose twice a day for five days. The goal is to determine if this treatment reduces the detection of the fungus. Individuals who have had a Candida auris infection or have been in contact with it at a participating facility might be suitable candidates for this trial. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Povidone Iodine?

Research has shown that using povidone iodine inside the nose is generally safe and well-tolerated. Studies have found it effective against many types of germs, including bacteria, viruses, and fungi. Most participants in these studies did not experience serious side effects. Other research has used this treatment without major safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for fungal infections that rely on oral or topical antifungal medications, intranasal Povidone Iodine is applied directly to the nasal passages. This unique delivery method allows for targeted action right where fungal spores may colonize, potentially reducing systemic side effects often associated with oral antifungals. Additionally, Povidone Iodine is known for its broad-spectrum antimicrobial properties, which include antifungal activity, making it a versatile option. Researchers are excited about the possibility of a quick, effective, and localized treatment that could work within days, offering a promising alternative to current therapies.

What is the effectiveness track record for Povidone Iodine in treating fungal infections?

Research shows that povidone iodine, which participants in this trial may receive as part of the "Intranasal Povidone Iodine" arm, acts as a powerful nasal antiseptic against bacteria and fungi. Studies have found it can significantly reduce germs, including fungi like Candida auris, even after just one use. Povidone iodine has been safely used in various nasal treatments and is known for its strong germ-killing abilities. It effectively reduces harmful germs in the nose. This treatment is already approved for other uses, demonstrating its effectiveness and safety. ^{1 4 5 6 7}

Who Is on the Research Team?

Mary K. Hayden, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I have had a C. auris infection or been colonized by it.

Patient in a participating facility

Exclusion Criteria

I do not speak English.

History of severe allergy to iodine-based products, defined as anaphylaxis or rash

Currently breastfeeding or pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive intranasal povidone iodine or no treatment for up to 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Povidone Iodine

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Routine care.

Group II: Intranasal Povidone Iodine Active Control 1 Intervention

Nasal iodophor applied twice daily for five days.

Povidone Iodine is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Betadine for:

• Skin disinfection before and after surgery
• Topical disinfection
• Eye conditions

Approved in United States as Betadine for:

• Topical disinfection
• Skin disinfection before and after surgery
• Eye conditions

Approved in Canada as Povidone iodine for:

• Topical disinfection
• Skin disinfection before and after surgery

Approved in Japan as Povidone iodine for:

• Topical disinfection
• Skin disinfection before and after surgery

Approved in China as Povidone iodine for:

• Topical disinfection
• Skin disinfection before and after surgery

Approved in Switzerland as Povidone iodine for:

• Topical disinfection
• Skin disinfection before and after surgery

Who Is Running the Clinical Trial?

Mary K Hayden

Lead Sponsor

Trials

1

Recruited

120+

Rush University Medical Center

Collaborator

Trials

448

Recruited

247,000+

RML Specialty Hospital

Collaborator

Trials

6

Recruited

1,700+

Published Research Related to This Trial

A 49-year-old woman with severe onychomycosis, resistant to all previous treatments, showed significant improvement using a novel formulation of 1% Povidone-iodine (PVP-I) combined with dimethyl sulfoxide (DMSO).

The success of this low-dose PVP-I/DMSO treatment suggests it could be a promising option for onychomycosis and highlights the need for further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onychomycosis treated with a dilute povidone-iodine/dimethyl sulfoxide preparation. Capriotti, K., Capriotti, JA.[2020]

Povidone-iodine (PVP-I) is an effective treatment for ocular infections, offering advantages such as a broader antibacterial spectrum, no observed bacterial resistance, and lower cost compared to other treatments.

PVP-I has been successfully used in various applications, including pre- and postoperative surgical prophylaxis and treatment of bacterial conjunctivitis, supported by studies conducted over the past 17 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. Isenberg, SJ., Apt, L., Campeas, D.[2017]

Povidone-iodine (PVP-I) is better tolerated and more effective than silver nitrate or erythromycin for preventing ophthalmia neonatorum, making it a promising alternative for eye care in newborns.

PVP-I demonstrated complete eradication of methicillin-resistant Staphylococcus aureus (MRSA) in a human skin model and is well tolerated by nasal epithelium, suggesting its potential as an antiseptic therapy for MRSA carriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New aspects of the tolerance of the antiseptic povidone-iodine in different ex vivo models. Kramer, A., Below, H., Behrens-Baumann, W., et al.[2017]

In a study of 11 women with refractory vulvovaginal yeast infections, oral voriconazole was effective, leading to symptom reduction and yeast clearance in 8 out of 11 participants after a 2-week treatment course.

The treatment was generally well-tolerated, with 10 out of 11 women completing the course, although some experienced mild side effects like nausea and photosensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and experiences of using oral voriconazole with or without concomitant topical agents to treat refractory vulvovaginal yeast infections. Morris, GC., Dean, G., Soni, S., et al.[2022]

Voriconazole, a common antifungal treatment for invasive aspergillosis, can cause rare but serious adverse reactions, such as psychosis, as seen in a case involving a man in his late 70s.

The patient's psychosis improved after stopping voriconazole and starting treatment with the antipsychotic haloperidol, highlighting the importance of monitoring for idiosyncratic reactions to this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voriconazole-induced psychosis in rhino-orbital invasive aspergillosis. Rekha, HS., Paramasivam, S., Raja, K., et al.[2023]

In a study of 138 patients treated with a high-dose voriconazole regimen of 12 mg/kg/day, nearly half (47%) had supratherapeutic trough levels, indicating the need for dose adjustments.

Using adjusted body weight for dosing in obese patients resulted in similar maintenance doses as total body weight dosing in non-obese patients, suggesting this approach is effective and sensible for managing voriconazole therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic drug monitoring and use of an adjusted body weight strategy for high-dose voriconazole therapy. Richards, PG., Dang, KM., Kauffman, CA., et al.[2018]

Voriconazole (VRC) is an effective antifungal agent approved for serious infections caused by various fungi, showing superior in vitro activity against Candida and Aspergillus species compared to other antifungals like fluconazole and itraconazole.

Clinical trials have confirmed VRC's efficacy in treating conditions such as candidal esophagitis and invasive aspergillosis, with a good safety profile, where the most common side effect is a temporary visual disturbance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Voriconazole -- better chances for patients with invasive mycoses. Ghannoum, MA., Kuhn, DM.[2022]

Candida species are becoming more common causes of infections in intensive care units, while mold infections are primarily affecting highly immunosuppressed patients, highlighting the need for effective antifungal treatments in these vulnerable populations.

New antifungal agents like echinocandins and voriconazole have improved treatment options, with echinocandins being very safe and well tolerated, while voriconazole offers a broad spectrum of activity but comes with potential side effects and drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fungal infections. Kauffman, CA.[2006]

Povidone iodine (PVP-I) demonstrated fungitoxic activity against various fungi, effectively limiting their growth on the outer layer of skin (stratum corneum) in a study using multiple concentrations (1.33% to 7.5%).

The effectiveness of PVP-I varied among different fungal species and strains, indicating that individual susceptibility of the skin also plays a role in how well it can prevent fungal infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine wash solutions in the prevention of superficial fungal infections; predictive evaluation using the corneofungimetry bioassay. Piérard, GE., Piérard-Franchimont, C., Arrese, JE.[2019]

Povidone iodine (PVPI) demonstrated the highest antibacterial activity among the three tested antiseptics, significantly reducing the frequency of resistant bacterial strains to just 4.6%.

The study utilized standardized methods to evaluate the chemical properties and antibacterial effectiveness of PVPI, iodized alcohol, and 70-degree alcohol, highlighting the importance of effective antiseptic management in reducing antibiotic use and preventing resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Antibacterial activity of antiseptics used at Military Teaching Hospital Mohamed V of Rabat]. Essayagh, T., Elameri, A., Zohoun, A., et al.[2017]

Liposomal formulations of povidone-iodine (PVP-I) are significantly less toxic to blood vessels compared to traditional aqueous PVP-I formulations, as demonstrated in a study using chick embryo models.

The study showed that liposomal PVP-I formulations reduced angiotoxic effects, such as coagulation and hemorrhages, indicating a safer option for local anti-infective treatments, especially in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative testing of liposomal and aqueous formulations of povidone-iodine for their angioirritative potential at the chorioallantoic membrane of ex ovo cultivated chick embryos. Wutzler, P., Sauerbrei, A., Härtl, A., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905910/

Efficacy of povidone-iodine nasal rinse and mouth wash in ... Among the in vivo studies, PVP-I was the most studied solution and was found to be the most effective regardless of concentration, with a Log10 reduction value ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04097613

Betadine Rinses for Chronic Rhinosinusitis Prospective ... Povidone Iodine solution is a nasal antiseptic. Its application has been shown to be clinically safe, tolerable and effective against bacteria and fungi ...

3. nature.com nature.com/articles/s41598-023-46792-8

Nasal microbiome and the effect of nasal decolonization ... In our study we noted that a single application of PVP-I solution resulted in a significant bioburden reduction even after 5 min and part of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7449185/

Povidone Iodine: Properties, Mechanisms of Action, and Role ... This procedure dramatically reduced the rate of nasal carriage of MRSA from 13.3% at baseline to 0% (79). STATE OF THE ART AND PERSPECTIVES.

5. withpower.com withpower.com/trial/phase-4-asymptomatic-infections-2024-c5387

Nasal Antiseptic for Fungal Infections This Phase 4 medical study run by Mary K Hayden is evaluating whether Povidone Iodine will have tolerable side effects & efficacy for patients with Fungal ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/0145561320957237

Efficacy of Povidone-Iodine Nasal and Oral Antiseptic ... Nasal and oral PVP-I antiseptic solutions are effective at inactivating the SARS-CoV-2 at a variety of concentrations after 60-second exposure times.

7. journals.asm.org journals.asm.org/doi/10.1128/aac.00682-20

Povidone Iodine: Properties, Mechanisms of Action, and Role ... One large randomized, placebo-controlled study evaluated the effects of intranasal PVP-I on nasal S. aureus colonization in patients ...