Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi

Conditions

• Blastomycosis
• Coccidioidomycosis
• Dimorphic Fungal Infection
• Endemic Mycoses
• Histoplasmosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oteseconazole — 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

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 Dates

First listed

Sep 4, 2026

Start date

Dec 1, 2026

Status verified

Aug 2026

Primary completion

Dec 1, 2028

Completion

Dec 1, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Oteseconazole Salvage or Consolidation Therapy
  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.

Primary Outcome Measure

Change in Symptom Status [ Time Frame: Baseline through 12 months ]

Central Contacts

• Matthew Pullen, MD
  615-504-2172
  [email protected]

Locations (4)

Find similar trials in Phoenix, AZ

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