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アスペルギルス種または他の糸状菌によって引き起こされた IFD の中国人患者の治療における Cresemba®

2026年5月26日 更新者：Pfizer

アスペルギルス種またはその他の糸状菌が原因の侵襲性真菌症（IFD）の中国人患者の一次治療におけるイサブコナゾールの安全性と有効性を評価するための単群、前向き、多施設研究

この研究は承認後のコミットメント研究であり、市販後にイサブコナゾール治療を受ける比較的大規模な中国人集団におけるイサブコナゾールの安全性と有効性をさらに評価するように設計されています。

これは、単群の前向き多施設研究です。 この研究は、アスペルギルス種または他の糸状菌によって引き起こされる、証明された、可能性の高い、または可能性のある侵襲性真菌症（IFD）の中国人患者を探しています。 参加者全員がイサブコナゾール治療を受けます。 この研究の最長治療期間は 84 日間です (IM と診断された参加者の場合は最大 180 日間)。

主な目的は、治療で発生した有害事象を観察することにより、イサブコナゾールの安全性と忍容性を特徴付けることです。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

70

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
      • Beijing、中国、100044
        • Peking University People's Hospital
      • Bengbu、中国、233000
        • the First Affiliated Hospital of Bengbu Medical College
      • Shanghai、中国、201800
        • Jiading Central Hospital
    • Anhui
      • Hefei、Anhui、中国、230001
        • The First Affiliated Hospital of USTC, Anhui Province Hospital
    • Guangdong
      • Guangzhou、Guangdong、中国、510180
        • Guangzhou First People's Hospital
      • Guangzhou、Guangdong、中国、510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou、Guangdong、中国、510280
        • ZhuJiang Hospital of Southern Medical University
      • Jieyang、Guangdong、中国、522095
        • Jieyang People's Hospital
    • Henan
      • Zhengzhou、Henan、中国、450003
        • Henan Provincial People's Hospital
    • Shandong
      • Liaocheng、Shandong、中国、252000
        • Liaocheng People's Hospital
      • Zibo、Shandong、中国、255036
        • Zibo Central Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huashan Hospital, Fudan University
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300020
        • Institute of Hematology, Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310003
        • The First Affiliated Hospital Zhejiang University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • Aspergillus 種、Mucorales 種、またはその他の糸状菌によって引き起こされる、証明された、可能性の高い、または可能性のある IFD
  • スクリーニング時の体重 >40 kg

除外基準:

  • 慢性アスペルギルス症、アスペルギルス腫、またはABPAのいずれか
  • -CD4数が200未満の進行したHIV感染症または後天性免疫不全症候群を定義する状態
  • 5日間生存する可能性が低い人または人工呼吸器の参加者
  • 重度の肝障害（Child-Pugh クラス C）
  • 家族性QT短縮症候群
  • -エファビレンツ、リトナビル、エトラビリン、リファンピシン/リファンピン、リファブチン、ナフシリン、ケトコナゾール、またはセントジョンズワートの併用 研究介入の最初の投与前の5日間

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：イサブコナゾール
これは単一群の研究であり、登録されたすべての参加者が研究薬を受け取ります。
薬：イサブコナゾール
これは単一群の研究であり、登録されたすべての参加者が研究介入を受けます。
他の名前：
  • クレセンバ®

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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE was an AE that started on or after the first administration of study intervention until 28 days after last dose of study intervention. AEs included both serious (SAE) and all non-serious adverse events (non-SAEs).
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
All-cause Mortality Rate Through Day 42
時間枠：After first dose of study intervention (Day 1) through Day 42
All-cause mortality included any death that occurred after first dose of study drug through Day 42 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 42 and b) unknown deaths: unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 42. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
After first dose of study intervention (Day 1) through Day 42
All-cause Mortality Rate Through Day 84
時間枠：After first dose of study intervention (Day 1) through Day 84
All-cause mortality included any death that occurred after first dose of study drug through Day 84 as following: a) known deaths: any death that occurred after first dose of study intervention through Day 84 and b) unknown (not actual deaths but the numbers were used in calculating all-cause mortality rate): participant was censored and was included in the reported data for this outcome measure if participant's survival status was missing or the last known alive date was before Day 84. All-cause mortality rate was defined as the percentage of participants with all-cause mortality (known deaths [actual] and unknown deaths [not actual but treated as deaths]) among the overall number of participants analyzed.
After first dose of study intervention (Day 1) through Day 84
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and End of Treatment (EOT): Modified Intent-to-Treat (mITT) Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 180)
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for:a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings;b)A success radiological response means:1) greater than equal to(>=) 90 percent (%)improvement from screening,2)>= 50% to less than(<)90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 180) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c)mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Overall Success Rate Based on Investigator's Assessment at Day 42, Day 84 and EOT: Mycological Intent-to-Treat IA (myITT-IA) Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 84)
Successful response was based on any one criterion from clinical, radiological or mycological response to be considered to have an overall outcome of success as the following. Criteria for: a)clinical response:1)resolution of all attributable clinical symptoms and physical findings 2)resolution of some attributable clinical symptoms and physical findings; b)A success radiological response means:1) >= 90 percent (%)improvement from screening, 2)>= 50% to < 90% improvement from screening for visits on Day 42, Day 84 and EOT(that is after Day 42), 3)>=25% to <50% improvement from screening (For Day 42 and EOT (that is before Day 84) for participants with proven or probable IFD and at Day 84, this would be considered unsuccessful) and 4) no signs on radiological images at screening (proven IFD only);c) mycological response:1)eradication and 2)presumed eradication. Overall success rate: percentage of participants with overall success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical Success Rate at Day 42, Day 84 and EOT: mITT Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Clinical Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 84)
Clinical response was categorized into: success, failure, and not applicable. Clinical success was based on any one of the following criteria: 1) resolution of all attributable clinical symptoms and physical findings and 2) resolution of some attributable clinical symptoms and/or physical findings. Assessment was based on investigator's assessment. Clinical success rate: percentage of participants with clinical success among all evaluable participants (excluding assessment not applicable participants) at specified time points. Clinical success rate: percentage of participants with clinical success at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological Success Rate at Day 42, Day 84 and EOT: mITT Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 180)
Mycological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
時間枠：Day 42, Day 84 and EOT (any day before or at Day 84)
Mycological response was categorized into: success, failure, and not applicable. Success mycological response was based on any one of the following criteria: 1) eradication: eradication of the original causative organism cultured or identified by histology/cytology at baseline and 2) presumed eradication: missing documentation of the eradication of the original causative organism at baseline plus resolution of all or some clinical symptoms and physical findings of IFD present at baseline and/or of those that appeared at a subsequent visit. Success rate: percentage of participants with successful mycological response at specified time points.
Day 42, Day 84 and EOT (any day before or at Day 84)
Radiological Success Rate at Day 42, Day 84 and EOT: mITT Population
時間枠：Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 180). Success rate: percentage of participants with successful radiological response at specified time points.
Day 42, Day 84 and EOT (any day or at before Day 180)
Radiological Success Rate at Day 42, Day 84 and EOT: myITT-IA Population
時間枠：Day 42, Day 84 and EOT (any day before Day 84)
Radiological response was categorized into: success, failure, and not applicable. A successful radiological response was based on any one of the following criteria: 1) >=90% improvement from screening, (2) >=50% to <90% improvement from screening for visits on Day 42, Day 84, and EOT (that is after Day 42), (3) >=25% to <50% improvement from screening for Day 42 and EOT (that is before Day 84). Success rate: percentage of participants with successful radiological response at specified time points.
Day 42, Day 84 and EOT (any day before Day 84)
Number of Participants With Treatment Related TEAEs
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. Treatment related TEAEs were TEAEs related to study intervention. AEs included both serious and all non-SAEs.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, is life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity and was a congenital anomaly/birth defect. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Study Intervention Discontinuation
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was an AE with that started on or after the first administration of study intervention until 28 days after last dose of study intervention. In this outcome measure, number of participants with TEAEs leading to study intervention discontinuation (during study treatment) were reported.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With TEAEs Leading to Death
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAEs was defined as an AE with an onset date on or after the date of informed consent until 28 days after discontinuation of drug. In this outcome measure, number of participants with TEAEs leading to death (during study treatment) were reported.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Death
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of participants with death due to any cause were reported in this outcome measure.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Laboratory Test Abnormalities
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Clinical laboratory abnormalities test criteria included, a) hematology: hemoglobin with primary criteria of <0.8* lower limit of normal (LLN), erythrocytes <0.8* LLN, platelets <0.5* LLN >1.75* upper limit of normal (ULN), leukocytes < 0.6* LLN and > 1.5* ULN, lymphocytes and neutrophils < 0.8* LLN and > 1.2* ULN. b) Chemistry: bilirubin and direct bilirubin >1.5* ULN, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase >3.0* ULN, urea nitrogen, urea and creatinine >1.3* ULN, sodium <0.95* LLN and potassium<0.9* LLN. c) urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin and bilirubin, urobilinogen, nitrite leukocyte esterase >= 1. Number of participants with any laboratory abnormalities were reported in this outcome measure.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Vital Signs
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Vital signs included systolic and diastolic blood pressures and pulse rate. Clinical significance of vital signs was judged by the investigator.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters as Per Pre-defined Criteria
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Predefined ECG criteria of clinical significance: a) heart rate (beats per minute [bpm]): value <40 and value >120; b) PR interval (millisecond [(msec)]: value>280; c) QRS interval (msec): value>120 d) QTc corrected using Fridericia's formula (QTcF) (msec): value >500 and new prolongation value >480 or increase >= 60. Only those pre-defined ECG categories for which non-zero data were available have been reported below.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Number of Participants With Abnormal Eye Examination
時間枠：From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
The eye examination included visual acuity, confrontational visual field testing and color perception testing. Any abnormality was assessed by a qualified ophthalmologist.
From start of study intervention on Day 1 up to 28 days after last dose of study intervention (For Isavuconazole IA group: approximately up to 112 days, for Isavuconazole IM group: approximately up to 208 days)
Plasma Concentration of Isavuconazole at Days 3, 7, 14 and EOT Visit
時間枠：Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)
Observed plasma concentrations of Isavuconazole were reported in this outcome measure.
Pre-dose (0 hours) and 1.5 hours post-dose on Day 3; pre-dose (0 hours) and 1.5, 3, 6, 12, 24 hours post dose on Days 7 and 14; pre-dose (0 hours) or 24 hours post-dose at EOT (any day before or at Day 180)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年2月7日

一次修了 (実際)

2025年4月11日

研究の完了 (実際)

2025年4月11日

試験登録日

最初に提出

2022年11月18日

QC基準を満たした最初の提出物

2022年11月18日

最初の投稿 (実際)

2022年11月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月27日

QC基準を満たした最後の更新が送信されました

2026年5月26日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • C3791001
  • NCT05630976 (レジストリ識別子：ClinicalTrials.gov)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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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

いいえ

米国FDA規制機器製品の研究

いいえ

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