Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Oteseconazole
DrugParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Oteseconazole Salvage or Consolidation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Symptom Status
Symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Time frame
Baseline through 12 months2
Change in Functional Status
Functional status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
Time frame
Baseline through 12 monthsSecondary outcomes
1
Serious Adverse Event Rate
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.
Time frame
Through 1 year2
Discontinuation of Study Drug Due to Therapeutic Failure
The number of participants who discontinue study drug due to therapeutic failure with worsening clinical symptoms will be assessed.
Time frame
Through study drug treatment period, up to 12 months3
Discontinuation of Study Drug Due to Adverse Events
The number of participants who discontinue study drug due to adverse events will be assessed.
Time frame
Through study drug treatment period, up to 12 months4
Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
The incidence of study drug discontinuation, dose reduction, or interruption due to toxicity or intolerance will be assessed by grade.
Time frame
Through study drug treatment period, up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov
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