120 Participants Needed

Nasal Antiseptic for Fungal Infections

Recruiting at 2 trial locations
SE
MK
Overseen ByMary K. Hayden, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mary K Hayden
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

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.234511

Research Team

MK

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
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Routine care.
Group II: Intranasal Povidone IodineActive Control1 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:

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Approved in European Union as Betadine for:
  • Skin disinfection before and after surgery
  • Topical disinfection
  • Eye conditions
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Approved in United States as Betadine for:
  • Topical disinfection
  • Skin disinfection before and after surgery
  • Eye conditions
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Approved in Canada as Povidone iodine for:
  • Topical disinfection
  • Skin disinfection before and after surgery
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Approved in Japan as Povidone iodine for:
  • Topical disinfection
  • Skin disinfection before and after surgery
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Approved in China as Povidone iodine for:
  • Topical disinfection
  • Skin disinfection before and after surgery
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Approved in Switzerland as Povidone iodine for:
  • Topical disinfection
  • Skin disinfection before and after surgery

Find a Clinic Near You

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

References

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]
Ocular applications of povidone-iodine. [2017]
Onychomycosis treated with a dilute povidone-iodine/dimethyl sulfoxide preparation. [2020]
New aspects of the tolerance of the antiseptic povidone-iodine in different ex vivo models. [2017]
Povidone-iodine wash solutions in the prevention of superficial fungal infections; predictive evaluation using the corneofungimetry bioassay. [2019]
Outcomes and experiences of using oral voriconazole with or without concomitant topical agents to treat refractory vulvovaginal yeast infections. [2022]
Voriconazole-induced psychosis in rhino-orbital invasive aspergillosis. [2023]
Therapeutic drug monitoring and use of an adjusted body weight strategy for high-dose voriconazole therapy. [2018]
Voriconazole -- better chances for patients with invasive mycoses. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Fungal infections. [2006]
[Antibacterial activity of antiseptics used at Military Teaching Hospital Mohamed V of Rabat]. [2017]