Nasal Antiseptic for Fungal Infections
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mary K Hayden
Disqualifiers: Severe iodine allergy, Pregnant, others
No Placebo Group
Prior Safety Data
Approved in 6 Jurisdictions
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.
12345Is 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.
678910How 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.
234511Eligibility 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
Trial 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)
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:
🇪🇺 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
RML Specialty HospitalHinsdale, IL
Rush University Medical CenterChicago, IL
RML Specialty HospitalChicago, IL
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Who Is Running the Clinical Trial?
Mary K HaydenLead Sponsor
Rush University Medical CenterCollaborator
RML Specialty HospitalCollaborator
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]Due to its excellent microbicidal activity, povidone-iodine (PVP-I) is used for local anti-infective treatment, especially for wound antisepsis of the skin. Previous studies have shown that liposomal PVP-I formulations are less cytotoxic and that a special liposomal PVP-I hydrogel provides wound healing efficacy.
Ocular applications of povidone-iodine. [2017]Ocular infections can have devastating consequences and may lead to blindness. Povidone-iodine (PVP-I) has many potential advantages over the currently used drugs, including a broader antibacterial spectrum, it turns the surface of the eye brown for a few minutes, bacterial resistance has not been seen and it is cheaper than other agents. PVP-I has made a significant contribution to pre- and postoperative ocular surgical prophylaxis, ophthalmia neonatorum prophylaxis and treatment of bacterial conjunctivitis. Scientific support for these applications includes studies conducted over the past 17 years, which are reviewed.
Onychomycosis treated with a dilute povidone-iodine/dimethyl sulfoxide preparation. [2020]Povidone-iodine (PVP-I) 10% aqueous solution is a well-known, nontoxic, commonly used topical antiseptic with no reported incidence of fungal resistance. We have been using a low-dose formulation of 1% PVP-I (w/w) in a solution containing dimethyl sulfoxide (DMSO) in our clinical practice for a variety of indications. Presented here is our clinical experience with this novel formulation in a severe case of onychomycosis that was resistant to any other treatment.
New aspects of the tolerance of the antiseptic povidone-iodine in different ex vivo models. [2017]Investigating new possibilities for the application of 1% (v/v) iodophors, povidone-iodine (PVP-I) was better tolerated in the HET-CAM or explant test than 1% (w/v) silver nitrate or tetracycline. After application to the eye, at least 2.6% of used iodine were adsorbed. Therefore PVP-I is more effective than silver nitrate or erythromycin, meaning a possible alternative for the prevention of ophthalmia neonatorum. PVP-I is more active against methicillin-resistant Staphylococcus aureus (MRSA) in a human ex vivo skin model, which results in a complete eradication of S. aureus in the nasal cavity of volunteers after 2 daily applications and will be better tolerated by human nasal cilial epithelium than chlorhexidine. Having the same clinical tolerance as mupirocin, PVP-I is a useful alternative for the antiseptic therapy of germ carriers of MRSA. The synthesis of proteoglycans in articular cartilage of bovine sesamoid bones was increased after application of 5% (v/v) PVP-I without any increase in catabolism revealing possibilities for the use as irrigation solution in the joint.
Povidone-iodine wash solutions in the prevention of superficial fungal infections; predictive evaluation using the corneofungimetry bioassay. [2019]Prevention of superficial mycoses remains a stubborn problem. The effect of antiseptics for that purpose is largely unknown. We studied the potential fungitoxic activity of povidone iodine (PVP-I) contained in wash solutions.
Outcomes and experiences of using oral voriconazole with or without concomitant topical agents to treat refractory vulvovaginal yeast infections. [2022]We describe 11 cases of refractory vulvovaginal yeast infections (RVVYI) treated using oral voriconazole with or without concomitant topical agents.
Voriconazole-induced psychosis in rhino-orbital invasive aspergillosis. [2023]Aspergillosis is a challenging fungal infection. Voriconazole is an antifungal drug belonging to the triazole group, commonly used for treating invasive aspergillosis, Cryptococcus neoformans and candida infections. We present a case of a man in his late 70s diagnosed with rhino-orbital invasive aspergillosis who developed voriconazole-induced psychosis as an idiosyncratic, adverse drug reaction (ADR); however, he responded to the cessation of intravenous voriconazole and, after starting on an oral antipsychotic, haloperidol. Clinicians need to be cognizant of this rare, idiosyncratic and iatrogenic ADR to voriconazole.
Therapeutic drug monitoring and use of an adjusted body weight strategy for high-dose voriconazole therapy. [2018]A high-dose 12 mg/kg/day (6 mg/kg twice daily) voriconazole regimen was recommended by the CDC to treat patients injected with contaminated methylprednisolone acetate that caused a multi-state fungal outbreak in 2012-13. Therapeutic drug monitoring results of this unique regimen are unknown, as is the most appropriate dosing weight for obese patients. We evaluated voriconazole trough measurements for this dosing scheme, as well as the use of adjusted body weight dosing for obese patients.
Voriconazole -- better chances for patients with invasive mycoses. [2022]The past two decades have witnessed an increase in serious fungal infections, without corresponding growth in available antifungal agents. Voriconazole (VRC) is a novel triazole antifungal, recently approved in Europe for treatment of serious infections caused by Aspergillus, Fusarium, Scedosporium, and resistant Candida species. Voriconazole has in vitro activity against yeasts and yeast-like fungi similar, or superior to, fluconazole (FLC), itraconazole (ITC) and amphotericin B (AMB). Candida albicans is generally the most susceptible yeast (VRC MIC subset90 of 0.06 microg/ml); C. krusei often has low MICs even in the face of FLU/ITC resistance. Voriconazole has demonstrated comparable, or better, in vitro activity than ITC and AMB against Aspergillus (mean MICs 0.19-0.58 microg/ml), Ascomycetes, Bipolaris, Fusarium, Blastomyces dermatitidis, Coccidioides immitis, dermatophytes, Histoplasma capsulatum, Malassezia, and Scedosporium angiospermum (P. boydii). The drug possesses potent fungicidal activity against moulds including Aspergillus, Scedosporium, and Fusarium. Fungicidal activity is likely due to the high affinity of VRC for fungal 14-alpha-demethylase, a concept supported by ultrastructural and biochemical analysis. Animal studies confirmed the activity of VRC against infections including pulmonary and invasive aspergillosis (IA); A. fumigatus endocarditis; fusariosis; pulmonary cryptococcosis; and invasive candidiasis. Most importantly, well-designed human clinical trials have confirmed the efficacy of VRC in the treatment of candidal esophagitis, IA, and febrile neutropenia. Smaller studies and case reports have shown VRC is useful for salvage therapy of IA, cerebral aspergillosis, Scedosporium, and other fungal infections. Clinical testing has shown VRC is safe and well tolerated; the most common side effect is benign, self-limited visual disturbance.
Fungal infections. [2006]Over the last decade, there have been changes in the epidemiology of fungal infections as well as dramatic improvements in the antifungal armamentarium. Candida species are an increasingly important cause of infection among patients in intensive care units. Mold infections continue to occur predominantly among highly immunosuppressed patients, such as those who have acute leukemia and those undergoing hematopoietic stem cell or solid organ transplantation. Aspergillus species remain the most common molds to cause invasive infection, but other environmental molds, such as Scedosporium, Fusarium, and various zygomycetes, including Rhizopus and Mucor, appear to be increasing in some medical centers. We now have available a new class of antifungal agents, the echinocandins, that act to damage the cell walls of Candida and Aspergillus species. Although limited in spectrum and only available in intravenous formulations, these agents are very safe and extremely well tolerated. Another new agent is the expanded spectrum triazole voriconazole. This agent has a very broad spectrum of activity, is available in both oral and intravenous formulations, and is approved for treatment of aspergillosis, other molds, and candidiasis. The major drawbacks with voriconazole are the number of drug-drug interactions and side effects, including rash, hepatitis, and visual disturbances. Treatment with amphotericin B, long the mainstay of antifungal therapy despite its inherent toxicity, is required much less often since the introduction of these new antifungal agents.
[Antibacterial activity of antiseptics used at Military Teaching Hospital Mohamed V of Rabat]. [2017]Antiseptics have a major role against the infections and their prevention. The good management of antiseptics allows the reduction of antibiotics use and thus the emergence of resistant bacterial strains. The evaluation of the antibacterial activity of three antiseptics (povidone iodine [PVPI], iodized alcohol and alcohol 70 degrees) used at HMIMV and taken from pharmacy was based on AFNOR method NF T 72-150. The analysis of their chemical properties were done by standardized methods (manganimetry, Bunsen's method, test to determine sodium thiosulfate levels [or sodium thiosulfate test] and Guy Lussac alcoholmeter). Our results were compared with those obtained in another two university hospitals of Rabat: Hospital of Speciality and Ibn Sina. The frequencies of resistant bacterial strains were respectively 4.6%, 30.7% and 15.4% to PVPI, alcohol iodized and alcohol 70 degrees . Our results have shown that the PVPI is the best antiseptic in our hospital.