Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Matthew Pullen, MD
- Telefonnummer: 615-504-2172
- E-mail: Pullen@umn.edu
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic
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Kontakt:
- Matthew Pullen, MD
- Telefonnummer: 615-504-2172
- E-mail: Pullen@umn.edu
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Tempe, Arizona, Forenede Stater, 85287
- Arizona State University - Tempe Campus
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California
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Davis, California, Forenede Stater, 95616
- University of California, Davis
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Kontakt:
- Matthew Pullen, MD
- Telefonnummer: 615-504-2172
- E-mail: Pullen@umn.edu
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Fresno, California, Forenede Stater, 93701-2302
- Ucsf Fresno
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Kontakt:
- Matthew Pullen, MD
- Telefonnummer: 615-504-2172
- E-mail: Pullen@umn.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Symptom Status
Tidsramme: Baseline through 12 months
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Symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
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Baseline through 12 months
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Change in Functional Status
Tidsramme: Baseline through 12 months
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Functional status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
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Baseline through 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Serious Adverse Event Rate
Tidsramme: Through 1 year
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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.
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Through 1 year
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Discontinuation of Study Drug Due to Therapeutic Failure
Tidsramme: Through study drug treatment period, up to 12 months
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The number of participants who discontinue study drug due to therapeutic failure with worsening clinical symptoms will be assessed.
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Through study drug treatment period, up to 12 months
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Discontinuation of Study Drug Due to Adverse Events
Tidsramme: Through study drug treatment period, up to 12 months
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The number of participants who discontinue study drug due to adverse events will be assessed.
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Through study drug treatment period, up to 12 months
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Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
Tidsramme: Through study drug treatment period, up to 12 months
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The incidence of study drug discontinuation, dose reduction, or interruption due to toxicity or intolerance will be assessed by grade.
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Through study drug treatment period, up to 12 months
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Incidence of Laboratory Adverse Events
Tidsramme: Through study drug treatment period, up to 12 months
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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.
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Through study drug treatment period, up to 12 months
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Change in PROMIS-29 Scores
Tidsramme: Baseline through study follow-up, up to 18 months
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PROMIS-29 scores will be assessed over time to evaluate changes in patient-reported health status and quality of life.
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Baseline through study follow-up, up to 18 months
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Change in Fatigue Symptom Status
Tidsramme: Baseline through 12 months
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Fatigue symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
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Baseline through 12 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Matthew Pullen, MD, University of Minnesota
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00027252, NB600395
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