MedTrace Logo

Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi

NCT07804368 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-09-04

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Matthew Pullen, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-12-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804368 on ClinicalTrials.gov