What this study is
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.
What's being tested
- Oteseconazole
Intervention · DRUG
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.
Study details
- Sponsor
- University of Minnesota
- Conditions
- Coccidioidomycosis · Blastomycosis · Histoplasmosis · Dimorphic Fungal Infection · Endemic Mycoses
- Enrolling
- 30 people
- Starts
- 2026-12-01
- Est. completion
- 2028-12-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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 that could limit protocol-specified assessments
- Females of childbearing potential
- Breast Cancer Resistance Protein substrate medication interaction that cannot be managed by switching medication, discontinuation, 50% dose reduction, or use of the lowest dose
- Children
- Pregnant women/persons
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openContact for 3 of 4 open sites
- Matthew Pullen, MD · Contact615-504-2172Pullen@umn.edu
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
Study team
Sponsor
University of Minnesota
Study ID STUDY00027252, NB600395
Principal investigator
Matthew Pullen, MD
University of Minnesota
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.