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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Matthew Pullen, MD
- Puhelinnumero: 615-504-2172
- Sähköposti: Pullen@umn.edu
Opiskelupaikat
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85054
- Mayo Clinic
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Ottaa yhteyttä:
- Matthew Pullen, MD
- Puhelinnumero: 615-504-2172
- Sähköposti: Pullen@umn.edu
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Tempe, Arizona, Yhdysvallat, 85287
- Arizona State University - Tempe Campus
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California
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Davis, California, Yhdysvallat, 95616
- University of California, Davis
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Ottaa yhteyttä:
- Matthew Pullen, MD
- Puhelinnumero: 615-504-2172
- Sähköposti: Pullen@umn.edu
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Fresno, California, Yhdysvallat, 93701-2302
- Ucsf Fresno
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Ottaa yhteyttä:
- Matthew Pullen, MD
- Puhelinnumero: 615-504-2172
- Sähköposti: Pullen@umn.edu
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Symptom Status
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Serious Adverse Event Rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Matthew Pullen, MD, University of Minnesota
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- STUDY00027252, NB600395
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