drugset / Trial / NCT07804368

Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi

NCT07804368 ↗

NaSingle-groupOpen-labelTreatment

Summary

This Phase II platform trial will evaluate the safety, tolerability, and effectiveness of investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis. The study will enroll adults who are receiving active antifungal therapy and who have intolerance, failure, or unavailability of standard first-line consolidation therapy. The first investigational agent evaluated in the platform trial is oteseconazole. Participants will receive study drug and complete follow-up assessments for symptom status, functional status, adverse events, laboratory safety, study drug discontinuation, and quality of life. Participants will be followed during therapy and for up to 6 months after therapy.

Timeline

Start
2026-12-01
Primary completion
2028-12-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oteseconazole Small molecule 600 mg Oral