Oteseconazole for Fungal Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Matthew Pullen, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults with certain serious fungal infections (like Valley Fever, blastomycosis, or histoplasmosis) who can't use standard antifungal treatments because they don't work well enough, aren't available, or cause bad side effects.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Oteseconazole
Trial Overview
The study is testing a new antifungal drug called oteseconazole as an alternative treatment. Participants will take the drug and be monitored for symptoms and side effects during therapy and up to 6 months after.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive oteseconazole as salvage or consolidation therapy for dimorphic fungal infection after intolerance, failure, or unavailability of standard first-line consolidation therapy. Participants will be followed for safety, tolerability, symptom status, functional status, adverse events, and treatment discontinuation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
University of Alabama at Birmingham
Collaborator
Centers for Disease Control and Prevention
Collaborator
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