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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Matthew Pullen, MD
- 电话号码：615-504-2172
- 邮箱：Pullen@umn.edu
学习地点
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Arizona
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Phoenix、Arizona、美国、85054
- Mayo Clinic
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接触：
- Matthew Pullen, MD
- 电话号码：615-504-2172
- 邮箱：Pullen@umn.edu
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Tempe、Arizona、美国、85287
- Arizona State University - Tempe Campus
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California
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Davis、California、美国、95616
- University of California, Davis
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接触：
- Matthew Pullen, MD
- 电话号码：615-504-2172
- 邮箱：Pullen@umn.edu
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Fresno、California、美国、93701-2302
- Ucsf Fresno
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接触：
- Matthew Pullen, MD
- 电话号码：615-504-2172
- 邮箱：Pullen@umn.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Symptom Status
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serious Adverse Event Rate
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Matthew Pullen, MD、University of Minnesota
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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