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.
What safety data exists for nasal antiseptic treatments like Povidone Iodine for fungal infections?The provided research does not contain safety data for nasal antiseptic treatments like Povidone Iodine. It focuses on the antifungal drug Voriconazole, discussing its efficacy, side effects, and therapeutic use in treating various fungal infections. Voriconazole is noted for its broad spectrum of activity and common side effects such as visual disturbances, rash, and hepatitis. However, no information is given about the safety or use of Povidone Iodine or related nasal antiseptics for fungal infections.47131415
What data supports the idea that Nasal Antiseptic for Fungal Infections is an effective treatment?The available research shows that povidone-iodine (PVP-I) is effective in treating various infections, although specific data on nasal antiseptic for fungal infections is limited. One study highlights its use in treating a severe case of onychomycosis, a fungal nail infection, which was resistant to other treatments. This suggests that PVP-I can be effective where other treatments fail. Additionally, PVP-I is noted for its broad antibacterial spectrum and lack of bacterial resistance, making it a strong alternative to other antiseptics. It is also more effective and better tolerated than some other antiseptics like silver nitrate and chlorhexidine in different applications, which supports its potential effectiveness in treating infections.123511
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Is the drug Povidone Iodine a promising treatment for fungal infections in the nose?The provided research articles do not discuss Povidone Iodine or its effectiveness for nasal fungal infections. Therefore, based on this information, we cannot determine if Povidone Iodine is a promising treatment for this condition.6891012
Eligibility Criteria
Inclusion Criteria
I have had a C. auris infection or been colonized by it.
Exclusion Criteria
I do not speak English.
Treatment Details
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
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.
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.
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.
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.
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.
[Actinomycotic lachrymal canaliculitis: a case report]. [2019]The authors report a case of unilateral chronic epiphora resistant to prolonged topical antibiotic treatment in a 62-year-old woman. Culture yielded some colonies of Actinomyces species. A dacryocystorhinostomy was found to be ineffective. Canaliculotomy with removal of cast resolved the chronic canaliculitis. Histological examination confirmed the diagnosis of solid cast of Actinomyces.
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.
Bilateral actinomycotic blepharokeratoconjunctivitis. [2007]Actinomycotic conjunctivitis is usually unilateral and secondary to canaliculitis. We report an unusual case of bilateral actinomycotic blepharokeratoconjunctivitis in the absence of canaliculitis. Keratitis occurred without any preceding ocular trauma. Both eyes had remissions and relapses in response to the antibiotic-steroid drops. Diagnosis of A. israelii infection was made on the basis of Gram staining, culture and biochemical characteristics. Complete excision of the conjunctival ulcer along with penicillin therapy resulted in cure. This case highlights that microorganisms of the order Actinomycetales should be considered in the differential diagnosis if conjunctivitis or keratitis shows a waxing and waning course.
Intracanalicular antibiotics may obviate the need for surgical management of chronic suppurative canaliculitis. [2022]Chronic suppurative lacrimal canaliculitis is an important cause of ocular surface discomfort. Treatment with topical antibiotics is often inadequate and surgical treatment by canaliculotomy and canalicular curettage has been the mainstay of treatment in the past. The role of canalicular antibiotic irrigation has been inadequately studied. We report the clinical features, microbiological profile and treatment outcome in a series of 12 patients with suppurative lacrimal canaliculitis. Two patients had Actinomyces infection, five had Nocardia infection and seven patients had polymicrobial infection. Three patients had resolution of canaliculitis on combination broad-spectrum topical antibiotic therapy using ciprofloxacin and fortified cefazolin. In nine patients, topical antibiotic therapy was combined with canalicular irrigation using fortified cefazolin. All patients had excellent resolution of canaliculitis without the need for surgical treatment. Availability of broad-spectrum antibiotics and canalicular irrigation may offer an alternative to surgery in the management of suppurative lacrimal canaliculitis.
Novel Therapy for Primary Canaliculitis: A Pilot Study of Intracanalicular Ophthalmic Corticosteroid/Antibiotic Combination Ointment Infiltration. [2022]In patients with primary canaliculitis, conservative medical therapy is associated with a high recurrence rate. Surgical treatments carry a great resolution rate but sometimes can result in the lacrimal pump dysfunction and canalicular scarring. The aim of this study is to introduce a minimally invasive approach, intracanalicular ophthalmic corticosteroid/antibiotic combination ointment infiltration (IOI, intracanalicular ointment infiltration), and to report our preliminary results for treating primary canaliculitis. In this retrospective, interventional case series, 68 consecutive patients with newly developed primary canaliculitis at a major tertiary eye center between January 2012 and January 2015. Thirty-six patients received conservative medical treatment alone (group 1; 36 eyes). Twenty-two patients and 10 medically uncontrolled patients from group 1 underwent IOI therapy (group 2; 32 eyes). Ten patients and 26 recurrent patients from group 1 and group 2 underwent surgery (group 3; 36 eyes). Patients were followed-up for at least 8 weeks. Clinical characteristics and outcomes were analyzed and compared. In this study, patients' age, sex, onset location, and durations of disease among 3 groups showed no significant difference. The resolution rate in group 2 was 72.7% (16/22) for new patients and 68.8% (22/32) for gross patients, respectively, both of which are higher than that of group 1 (22.2%, 10/36) but lower than that of group 3 (100%, 36/36). Of group 3, 2 patients received 2 surgical interventions and resolved finally. Microbiological workup was available in 51 patients. The most common isolates were staphylococcus species (27.9%) and streptococcus species (20%). Canalicular laceration developed in 1 patient during the IOI procedure and 1 patient undergoing surgery. Only 2 had postoperative lacrimal pump dysfunction and 1 had canalicular scarring in group 3. The IOI may be an effective and minimally invasive technique for treating primary canaliculitis and obviate the need for further intensive surgery.
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.
Microbiology of primary acquired nasolacrimal duct obstruction: simple epiphora, acute dacryocystitis, and chronic dacryocystitis. [2022]The aim of this study was to determine the microbiology of primary acquired nasolacrimal duct obstruction (PANDO) and its antimicrobial susceptibilities.
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.
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.