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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lingai Pan, MD
- Número de teléfono: +86 17708130236
- Correo electrónico: panlingai2004@163.com
Ubicaciones de estudio
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Sichuan
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Chengdu, Sichuan, Porcelana, 610072
- Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
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Contacto:
- Lingai Pan, MD
- Número de teléfono: +86 17708130236
- Correo electrónico: panlingai2004@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
Otros nombres:
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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28-Day Clinical Response Rate
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mycological Clearance Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lingai Pan, MD, Sichuan Provincial People's Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KC2025-JX-0390WLH-06 (Otro número de subvención/financiamiento: Beijing Science and Technology Innovation Medical Development Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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