Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients (LAMB-SOT)
A Real-World Observational Study of the Effectiveness, Safety, and Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease
This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.
This is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.
The study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.
The primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.
The study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Lingai Pan, MD
- 電話番号：+86 17708130236
- メール：panlingai2004@163.com
研究場所
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-
Sichuan
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Chengdu、Sichuan、中国、610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
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コンタクト：
- Lingai Pan, MD
- 電話番号：+86 17708130236
- メール：panlingai2004@163.com
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18 to 75 years.
- Recipient of a solid organ transplant.
- Diagnosis of invasive fungal disease (IFD) according to EORTC/MSGERC criteria.
- Receiving liposomal amphotericin B therapy as part of routine clinical care.
- Provision of informed consent for prospective participants.
Exclusion Criteria:
- Known hypersensitivity to amphotericin B formulations.
- Severe hepatic dysfunction (ALT or AST >5× upper limit of normal, or total bilirubin >2× upper limit of normal).
- Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.
- Pregnancy or breastfeeding.
- Participation judged inappropriate by the investigator.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Liposomal Amphotericin B Cohort
Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy.
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Liposomal amphotericin B administered for treatment of proven, probable, or possible invasive fungal disease in solid organ transplant recipients according to routine clinical practice.
Dose adjustment and treatment duration are determined by treating physicians.
他の名前：
|
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Historical Control Cohort
Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens.
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Alternative systemic antifungal agents including azoles, echinocandins, or other standard antifungal therapies administered according to routine clinical practice in historical control patients with invasive fungal disease.
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 |
|---|---|---|
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28-Day Clinical Response Rate
時間枠：Day 28
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Proportion of participants achieving complete or partial clinical response at Day 28 after initiation of antifungal therapy.
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Day 28
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84-Day All-Cause Mortality
時間枠：Day 84
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All-cause mortality occurring within 84 days after initiation of antifungal therapy.
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Day 84
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mycological Clearance Rate
時間枠：Day 28
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Proportion of participants with documented clearance of fungal pathogens.
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Day 28
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Acute Kidney Injury
時間枠：Baseline through Day 84
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Occurrence of acute kidney injury during antifungal treatment.
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Baseline through Day 84
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Electrolyte Abnormalities
時間枠：Baseline through Day 84
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Occurrence of hypokalemia, hypomagnesemia, or other treatment-related electrolyte disturbances.
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Baseline through Day 84
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Breakthrough Fungal Infection
時間枠：Baseline through Day 84
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Occurrence of breakthrough invasive fungal infection during antifungal therapy.
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Baseline through Day 84
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Antifungal Treatment Discontinuation Due to Adverse Events
時間枠：Baseline through Day 84
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Permanent discontinuation of antifungal therapy because of treatment-related adverse events.
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Baseline through Day 84
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Liposomal Amphotericin B Plasma Concentration
時間枠：Baseline through Day 84
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Plasma concentration of liposomal amphotericin B measured during antifungal therapy.
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Baseline through Day 84
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Association Between Liposomal Amphotericin B Exposure and Clinical Response
時間枠：Baseline through Day 84
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Relationship between liposomal amphotericin B plasma concentration and clinical response.
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Baseline through Day 84
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Association Between Liposomal Amphotericin B Exposure and Adverse Events
時間枠：Baseline through Day 84
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Relationship between liposomal amphotericin B plasma concentration and treatment-related adverse events, including nephrotoxicity and electrolyte abnormalities.
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Baseline through Day 84
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協力者と研究者
捜査官
- 主任研究者：Lingai Pan, MD、Sichuan Provincial People's Hospital
出版物と役立つリンク
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- KC2025-JX-0390WLH-06 (その他の助成金/資金番号：Beijing Science and Technology Innovation Medical Development Foundation)
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?
IPD プランの説明
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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