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.
調査の概要
状態
介入・治療
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Matthew Pullen, MD
- 電話番号：615-504-2172
- メール：Pullen@umn.edu
研究場所
-
-
Arizona
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Phoenix、Arizona、アメリカ、85054
- Mayo Clinic
-
コンタクト：
- Matthew Pullen, MD
- 電話番号：615-504-2172
- メール：Pullen@umn.edu
-
Tempe、Arizona、アメリカ、85287
- Arizona State University - Tempe Campus
-
-
California
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Davis、California、アメリカ、95616
- University of California, Davis
-
コンタクト：
- Matthew Pullen, MD
- 電話番号：615-504-2172
- メール：Pullen@umn.edu
-
Fresno、California、アメリカ、93701-2302
- Ucsf Fresno
-
コンタクト：
- Matthew Pullen, MD
- 電話番号：615-504-2172
- メール：Pullen@umn.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Symptom Status
時間枠：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.
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Baseline through 12 months
|
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Change in Functional Status
時間枠：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.
|
Baseline through 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serious Adverse Event Rate
時間枠：Through 1 year
|
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
時間枠：Through study drug treatment period, up to 12 months
|
The number of participants who discontinue study drug due to therapeutic failure with worsening clinical symptoms will be assessed.
|
Through study drug treatment period, up to 12 months
|
|
Discontinuation of Study Drug Due to Adverse Events
時間枠：Through study drug treatment period, up to 12 months
|
The number of participants who discontinue study drug due to adverse events will be assessed.
|
Through study drug treatment period, up to 12 months
|
|
Study Drug Discontinuation, Dose Reduction, or Interruption Due to Toxicity or Intolerance
時間枠：Through study drug treatment period, up to 12 months
|
The incidence of study drug discontinuation, dose reduction, or interruption due to toxicity or intolerance will be assessed by grade.
|
Through study drug treatment period, up to 12 months
|
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Incidence of Laboratory Adverse Events
時間枠：Through study drug treatment period, up to 12 months
|
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
時間枠：Baseline through study follow-up, up to 18 months
|
PROMIS-29 scores will be assessed over time to evaluate changes in patient-reported health status and quality of life.
|
Baseline through study follow-up, up to 18 months
|
|
Change in Fatigue Symptom Status
時間枠：Baseline through 12 months
|
Fatigue symptom status change over time will be assessed using a 10-point visual analogue scale queried monthly through follow-up surveys.
|
Baseline through 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Matthew Pullen, MD、University of Minnesota
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00027252, NB600395
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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