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Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
Sponsor: University of Minnesota
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-12-01
Completion Date
2028-12-01
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Oteseconazole
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.
Locations (4)
Mayo Clinic
Phoenix, Arizona, United States
Arizona State University - Tempe Campus
Tempe, Arizona, United States
University of California, Davis
Davis, California, United States
UCSF Fresno
Fresno, California, United States