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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Matthew Pullen, MD
- Telefonní číslo: 615-504-2172
- E-mail: Pullen@umn.edu
Studijní místa
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Arizona
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Phoenix, Arizona, Spojené státy, 85054
- Mayo Clinic
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Kontakt:
- Matthew Pullen, MD
- Telefonní číslo: 615-504-2172
- E-mail: Pullen@umn.edu
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Tempe, Arizona, Spojené státy, 85287
- Arizona State University - Tempe Campus
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California
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Davis, California, Spojené státy, 95616
- University of California, Davis
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Kontakt:
- Matthew Pullen, MD
- Telefonní číslo: 615-504-2172
- E-mail: Pullen@umn.edu
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Fresno, California, Spojené státy, 93701-2302
- Ucsf Fresno
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Kontakt:
- Matthew Pullen, MD
- Telefonní číslo: 615-504-2172
- E-mail: Pullen@umn.edu
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Symptom Status
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Serious Adverse Event Rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Matthew Pullen, MD, University of Minnesota
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00027252, NB600395
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