Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi

August 31, 2026 updated by: University of Minnesota

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Dimorphic fungal infections, including coccidioidomycosis, blastomycosis, and histoplasmosis, are commonly treated with azole antifungals such as itraconazole or fluconazole as consolidation therapy. However, some patients experience intolerance, treatment failure, drug interactions, toxicity, or lack of access to standard first-line consolidation therapy. For these patients, treatment options are limited.

This study is an open-label, single-arm Phase II platform trial designed to evaluate investigational antifungal agents as salvage or consolidation therapy in adults with dimorphic fungal infections. The first investigational agent evaluated in this platform is oteseconazole.

Eligible participants will be adults with coccidioidomycosis, blastomycosis, or histoplasmosis who are on active therapy, are expected to require at least 6 additional months of antifungal therapy, and have intolerance, failure, or unavailability of current first-line consolidation therapy. Participants will complete screening and informed consent through REDCap. Study drug will be mailed to participants by the central pharmacy after enrollment.

Participants will complete monthly follow-up surveys assessing symptom status, functional status, quality of life, antifungal therapy changes, and treatment tolerance. Safety monitoring will include adverse event tracking, serious adverse event reporting, and laboratory assessments. Participants will be followed for up to 18 months, including the treatment period and 6 months of post-therapy follow-up.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Matthew Pullen, MD
  • Phone Number: 615-504-2172
  • Email: Pullen@umn.edu

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
        • Contact:
      • Tempe, Arizona, United States, 85287
        • Arizona State University - Tempe Campus
    • California
      • Davis, California, United States, 95616
        • University of California, Davis
        • Contact:
      • Fresno, California, United States, 93701-2302
        • UCSF Fresno
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • VIVJOA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom Status
Time Frame: Baseline through 12 months
Symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Baseline through 12 months
Change in Functional Status
Time Frame: Baseline through 12 months
Functional status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Baseline through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Event Rate
Time Frame: Through 1 year
Serious adverse event rate will be assessed through 1 year, including events such as death, all-cause re-hospitalization, permanent neurologic deficit, and other serious adverse events.
Through 1 year
Discontinuation of Study Drug Due to Therapeutic Failure
Time Frame: Through study drug treatment period, up to 12 months
The number of participants who discontinue study drug due to therapeutic failure with worsening clinical symptoms will be assessed.
Through study drug treatment period, up to 12 months
Discontinuation of Study Drug Due to Adverse Events
Time Frame: Through study drug treatment period, up to 12 months
The number of participants who discontinue study drug due to adverse events will be assessed.
Through study drug treatment period, up to 12 months
Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
Time Frame: Through study drug treatment period, up to 12 months
The incidence of study drug discontinuation, dose reduction, or interruption due to toxicity or intolerance will be assessed by grade.
Through study drug treatment period, up to 12 months
Incidence of Laboratory Adverse Events
Time Frame: Through study drug treatment period, up to 12 months
Laboratory adverse events will be assessed with focus on alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and direct, indirect, and total bilirubin, using the NIH DAIDS Adverse Event Grading document.
Through study drug treatment period, up to 12 months
Change in PROMIS-29 Scores
Time Frame: Baseline through study follow-up, up to 18 months
PROMIS-29 scores will be assessed over time to evaluate changes in patient-reported health status and quality of life.
Baseline through study follow-up, up to 18 months
Change in Fatigue Symptom Status
Time Frame: Baseline through 12 months
Fatigue symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Baseline through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

University of Alabama at Birmingham
Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Matthew Pullen, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 31, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00027252, NB600395

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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