University of Minnesota
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.
Dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, are commonly treated with azole antifungals such as itraconazole or fluconazole as consolidation therapy. However, some patients experience intolerance, treatment failure, drug interactions, toxicity, or lack of access to standard first-line consolidation therapy. For these patients, treatment options are limited. This study is an open-label, single-arm Phase II platform trial designed to evaluate investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal in…
Inclusion Criteria: * Diagnosis of coccidioidomycosis, blastomycosis, or histoplasmosis and on active therapy * Age 18 years or older * Anticipated need for at least 6 additional months of antifungal therapy at enrollment * Intolerance, failure, or unavailability of current first-line consolidation therapy Exclusion Criteria: * Currently hospitalized * Central nervous system involvement of coccidioidomycosis, blastomycosis, or histoplasmosis * Previous administration of or allergy to study drug * Any condition for which participation would not be in the best interest of the participant or t…
Participants will receive oral oteseconazole 600 mg twice daily for 12 days, followed by 600 mg weekly. Total treatment duration depends on diagnosis: up to 52 weeks for coccidioidomycosis, 26 weeks for blastomycosis, and 26 weeks for histoplasmosis.