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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lingai Pan, MD
- 전화번호: +86 17708130236
- 이메일: panlingai2004@163.com
연구 장소
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Sichuan
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Chengdu, Sichuan, 중국, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
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연락하다:
- Lingai Pan, MD
- 전화번호: +86 17708130236
- 이메일: panlingai2004@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
다른 이름들:
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-Day Clinical Response Rate
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mycological Clearance Rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Lingai Pan, MD, Sichuan Provincial People's Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- KC2025-JX-0390WLH-06 (기타 보조금/기금 번호: Beijing Science and Technology Innovation Medical Development Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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