Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01891331 (A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- OteseconazoleRevista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2026Pooled it
- Oteseconazole versus fluconazole for the treatment of severe vulvovaginal candidiasis: a multicenter, randomized, double-blinded, phase 3 trial.Antimicrobial agents and chemotherapy · 2024Trial
- State-of-the-Art Review: Managing Vulvovaginal Candidiasis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Review
- Efficacy and Safety of Oteseconazole in Severe Vulvovaginal Candidiasis Categorized byDrug design, development and therapy · 2026Observational
- The Upcoming Antifungal Drugs in Clinical Development for the Treatment of Invasive Candidiasis.Infection and drug resistance · 2026Review
- Unravelling azole resistance in fungal pathogens: molecular mechanisms, diagnostic challenges, and therapeutic strategies.World journal of microbiology & biotechnology · 2025Review
- Use of Intravaginal Cooling to Provide Symptom Relief in Women With Vulvovaginal Candidiasis and Reduce Immunopathology in an Accompanying Mouse Model.The Journal of infectious diseases · 2025Article
- Beyond Conventional Antifungals: Combating Resistance Through Novel Therapeutic Pathways.Pharmaceuticals (Basel, Switzerland) · 2025Review
- The Significance of Mono- and Dual-Effective Agents in the Development of New Antifungal Strategies.Chemical biology & drug design · 2025Review
- Study on the impact of biofilm formation byFrontiers in cellular and infection microbiology · 2025Article
- Three-Dose Antifungal Treatment Improves the Efficacy for Severe Vulvovaginal Candidiasis.Mycopathologia · 2024Article
- Amphotericin B in the Era of New Antifungals: Where Will It Stand?Journal of fungi (Basel, Switzerland) · 2024Review
- "Efficacy and safety of oteseconazole in recurrent vulvovaginal candidiasis (RVVC) - A systematic review and meta-analysis".Heliyon · 2023Article
- Treatment of Vulvovaginal Candidiasis-An Overview of Guidelines and the Latest Treatment Methods.Journal of clinical medicine · 2023Review
- A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022.Naunyn-Schmiedeberg's archives of pharmacology · 2023Review
- Antifungal chemotherapies and immunotherapies for the future.Parasite immunology · 2023Review
- Mucormycosis: A hidden mystery of fungal infection, possible diagnosis, treatment and development of new therapeutic agents.European journal of medicinal chemistry · 2023Review
- Novel Therapeutic Approaches to Invasive Candidiasis: Considerations for the Clinician.Infection and drug resistance · 2023Review
- Synthesis, characterization, and antibacterial activities of a heteroscorpionate derivative platinum complex against methicillin-resistantFrontiers in cellular and infection microbiology · 2023Article
- New Antifungal Agents with Azole Moieties.Pharmaceuticals (Basel, Switzerland) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundAcute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (oteseconazole) is an oral agent with increased selectivity for fungal CYP51. In this phase 2 clinical study, we evaluated the efficacy and safety of VT-1161 vs fluconazole in participants with moderate to severe acute VVC.
methodsParticipants presenting with an acute episode of VVC (n = 55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days or to receive a single dose of fluconazole 150 mg (FDA-approved dose to treat acute VVC). Participants were followed for 6 months. The primary outcome was the proportion of participants with therapeutic (clinical and mycological) cure at day 28.
resultsA larger proportion of participants in the per-protocol population experienced therapeutic cure in the VT-1161 300 mg q.d. (75.0%), VT-1161 600 mg q.d. (85.7%), and VT-1161 600 mg b.i.d. (78.6%) groups vs the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no participants in the VT-1161 groups vs 28.5% and 46.1% in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported.
conclusionsThe majority of participants across all treatment groups achieved therapeutic cure at day 28. VT-1161 was well tolerated at all dose levels through 6 months of follow-up. CLINICAL TRIALS REGISTRATION: NCT01891331.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.