Platform Trial for Salvage Consolidation Therapy in Dimorphic Fungi
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Change in Symptom Status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant women/persons
- •Prisoners
- •Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
研究组 & 干预措施
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.
干预措施: Oteseconazole (Drug)
结局指标
主要结局
Change in Symptom Status
时间窗: 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.
Change in Functional Status
时间窗: 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.
次要结局
- Serious Adverse Event Rate(Through 1 year)
- Discontinuation of Study Drug Due to Therapeutic Failure(Through study drug treatment period, up to 12 months)
- Discontinuation of Study Drug Due to Adverse Events(Through study drug treatment period, up to 12 months)
- Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance(Through study drug treatment period, up to 12 months)
- Incidence of Laboratory Adverse Events(Through study drug treatment period, up to 12 months)
- Change in PROMIS-29 Scores(Baseline through study follow-up, up to 18 months)
- Change in Fatigue Symptom Status(Baseline through 12 months)