Oteseconazole for Fungal Infections

Not yet recruiting at 3 trial locations
MP
Overseen ByMatthew Pullen, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

MP

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

I will need antifungal treatment for at least 6 more months.
I am being treated for a fungal infection like coccidioidomycosis, blastomycosis, or histoplasmosis.
I am 18 years old or older.
See 1 more

Exclusion Criteria

Prisoners
Currently hospitalized
Any condition for which participation would not be in the best interest of the participant or that could limit protocol-specified assessments
See 9 more

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

Group I: Oteseconazole Salvage or Consolidation TherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Centers for Disease Control and Prevention

Collaborator

Trials
902
Recruited
25,020,000+