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Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients (TRIM-1)

2026年7月16日 更新者：Zhibin Xu

Therapeutic Drug Monitoring of Isavuconazole in Solid Organ and Hematopoietic Stem Cell Transplant Recipients: A Single-Center Retrospective Cohort Study of Plasma Trough Exposure, Its Determinants, and Hepatic Safety

Isavuconazole is an antifungal medicine used to prevent or treat serious fungal infections in people who have received a solid organ transplant (mainly lung, and also kidney or liver) or a hematopoietic stem cell (bone marrow) transplant. Because these patients take medicines that suppress the immune system, they are at high risk of fungal infections. The amount of isavuconazole in the blood can vary widely from person to person, and it is not fully understood what drives these differences or whether higher blood levels are linked to side effects such as liver problems.This study reviews the medical records of transplant recipients who were treated with isavuconazole at a single hospital in China between January 2024 and April 2026. Using results from routine therapeutic drug monitoring (blood tests that measure the drug level), the researchers describe how isavuconazole blood levels are distributed, how much they vary within and between patients, and which clinical and genetic factors are associated with higher or lower levels. The study also examines whether isavuconazole blood levels are related to liver function abnormalities and to survival. Because this is an observational study, no treatment was assigned for research purposes; the study only analyzes data collected during routine clinical care. The findings are intended to help guide individualized dosing and monitoring of isavuconazole in transplant recipients.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a single-center, retrospective, observational cohort study conducted at the First Affiliated Hospital of Guangzhou Medical University. It includes solid organ transplant (lung, kidney, liver) and hematopoietic stem cell transplant recipients who received isavuconazole for the prophylaxis or treatment of invasive fungal infections between January 2024 and April 2026 and who had at least one plasma isavuconazole trough concentration measured by routine therapeutic drug monitoring (TDM).

The primary objective is to characterize the distribution and the within- and between-patient variability of isavuconazole plasma trough concentrations and to identify clinical and pharmacogenetic determinants of drug exposure. Secondary objectives include describing attainment of a pre-specified target trough window (1-7 µg/mL); the relationship between isavuconazole exposure and calcineurin-inhibitor (tacrolimus, cyclosporine) concentrations; and the association of isavuconazole exposure with hepatic function abnormalities and all-cause mortality.

Demographic, clinical, laboratory, immunosuppressant, CYP3A5 genotype, and TDM data are extracted from medical records. Trough concentrations are analyzed at both the measurement level and the patient level. Determinants of log-transformed trough concentration are evaluated using linear mixed-effects models with a patient-level random intercept to account for repeated measurements. Subgroup analyses are pre-specified by transplant type (lung, kidney, liver, hematopoietic stem cell), treatment scenario (prophylaxis vs treatment), age (adult vs pediatric), and CYP3A5 genotype, with case-series description for small subgroups; a sensitivity analysis restricted to adults is also performed. No study intervention is assigned; all data reflect routine clinical care. The study is reported in accordance with the STROBE statement and was approved by the institutional ethics committee (approval number ES-2025-K203-01).

研究の種類

観察的

入学 (実際)

110

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
    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • The First Affiliated Hospital of Guangzhou Medical 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

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

Consecutive solid organ (lung, kidney, liver) and hematopoietic stem cell transplant recipients who received isavuconazole and underwent routine therapeutic drug monitoring at a single tertiary-care hospital in China between January 2024 and April 2026. A total of 110 recipients were included (89 lung, 6 kidney, 2 liver, and 13 hematopoietic stem cell transplant), contributing 427 trough concentration measurements.

説明

Inclusion Criteria:

  • Recipients of solid organ transplantation (lung, kidney, or liver) or hematopoietic stem cell transplantation
  • Received isavuconazole for prophylaxis or treatment of invasive fungal infection during the study period, with traceable prescription and administration records
  • Isavuconazole treatment duration of at least 7 days and at least one measured plasma isavuconazole trough concentration
  • Adequate follow-up information to assess the main study variables

Exclusion Criteria:

  • No available plasma isavuconazole trough concentration
  • Incomplete key clinical or dosing records precluding analysis

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

コホートと介入

グループ/コホート
介入・治療
Treatment cohort
Transplant recipients who received isavuconazole for the treatment of suspected or documented invasive fungal infection.
薬：Isavuconazole
Isavuconazole administered orally or intravenously as part of routine clinical care; plasma trough concentrations measured by routine therapeutic drug monitoring.
Prophylaxis cohort
Transplant recipients who received isavuconazole for the prophylaxis of invasive fungal infection.
薬：Isavuconazole
Isavuconazole administered orally or intravenously as part of routine clinical care; plasma trough concentrations measured by routine therapeutic drug monitoring.

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
Plasma isavuconazole trough concentration
時間枠：During the study period (January 2024 to April 2026)
Distribution (median [IQR], range) and within- and between-patient variability (coefficient of variation) of plasma isavuconazole trough concentrations obtained by routine therapeutic drug monitoring.
During the study period (January 2024 to April 2026)

二次結果の測定

結果測定
メジャーの説明
時間枠
Determinants of isavuconazole trough concentration
時間枠：During the study period (January 2024 to April 2026)
Clinical and pharmacogenetic factors independently associated with log-transformed trough concentration, estimated by linear mixed-effects models (e.g., weight-adjusted daily dose, serum albumin, total bilirubin, estimated glomerular filtration rate, hemoglobin, transplant type, CYP3A5 genotype).
During the study period (January 2024 to April 2026)
Attainment of the target trough window (1-7 µg/mL)
時間枠：During the study period (January 2024 to April 2026)
Proportion of trough measurements falling within the pre-specified target window of 1-7 µg/mL, and below (<1 µg/mL) or above (>7 µg/mL) it.
During the study period (January 2024 to April 2026)
Association between isavuconazole exposure and hepatic function abnormality
時間枠：During the study period (January 2024 to April 2026)
Association between isavuconazole trough concentration and hepatic function abnormality, defined as alanine or aspartate aminotransferase >120 U/L and/or total bilirubin >21 µmol/L.
During the study period (January 2024 to April 2026)
Correlation between isavuconazole and calcineurin-inhibitor concentrations
時間枠：During the study period (January 2024 to April 2026)
Spearman correlation between concurrently measured isavuconazole trough concentrations and tacrolimus or cyclosporine blood concentrations.
During the study period (January 2024 to April 2026)
All-cause mortality
時間枠：During the study period (January 2024 to April 2026)
All-cause mortality during follow-up and its association with isavuconazole exposure.
During the study period (January 2024 to April 2026)

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

Zhibin Xu

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)

2024年1月1日

一次修了 (実際)

2026年4月1日

研究の完了 (実際)

2026年4月1日

試験登録日

最初に提出

2026年7月16日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7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

  • ES-2025-K203-01

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?

いいえ

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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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