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

Trial Summary

What is the purpose of this trial?

This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.

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 data supports the effectiveness of the treatment Povidone Iodine for fungal infections?

Povidone-iodine (PVP-I) has been shown to be effective in treating onychomycosis (a fungal nail infection) and has no reported fungal resistance, suggesting it may be useful for other fungal infections as well. ^{1 2 3 4 5}

Is Povidone Iodine safe for use in humans?

The provided research articles do not contain safety data on Povidone Iodine or its related names for treating fungal infections or other conditions. ^{6 7 8 9 10}

How is the drug Povidone Iodine unique for treating fungal infections?

Povidone Iodine (PVP-I) is unique for treating fungal infections because it is a well-known antiseptic with no reported fungal resistance, and it can be used in a low-dose formulation that has shown effectiveness in cases resistant to other treatments. Additionally, it is more tolerated and effective against certain bacteria compared to other antiseptics, making it a versatile option for various infections. ^{2 3 4 5 11}

Research Team

Mary K. Hayden, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Povidone Iodine

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 (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]

References

1. Switzerland 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. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Ocular applications of povidone-iodine. [2017]

3. New Zealand pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

New aspects of the tolerance of the antiseptic povidone-iodine in different ex vivo models. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Povidone-iodine wash solutions in the prevention of superficial fungal infections; predictive evaluation using the corneofungimetry bioassay. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Outcomes and experiences of using oral voriconazole with or without concomitant topical agents to treat refractory vulvovaginal yeast infections. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Voriconazole-induced psychosis in rhino-orbital invasive aspergillosis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Therapeutic drug monitoring and use of an adjusted body weight strategy for high-dose voriconazole therapy. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Voriconazole -- better chances for patients with invasive mycoses. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Fungal infections. [2006]

11. France pubmed.ncbi.nlm.nih.gov

[Antibacterial activity of antiseptics used at Military Teaching Hospital Mohamed V of Rabat]. [2017]