Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients
26 de abril de 2026 actualizado por: Xiao-Jun Huang, Peking University People's Hospital
A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Amphotericin B in the Treatment of Breakthrough Invasive Fungal Disease in Hematological Patients Receiving Triazole Prophylaxis
The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.
The main questions it aims to answer are:
- What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?
- What medical problems do participants have when taking amphotericin B?
- What is the 6-week (42-day) overall survival rate after starting treatment?
This is a single-arm, prospective study. Participants will:
- Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks.
- Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.
- Have safety monitoring including liver and kidney function, electrolytes, and ECG.
- Be followed for treatment response and survival.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
15
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rui Ma
- Número de teléfono: +86 18834948122
- Correo electrónico: marui_pku_ed@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana
- Peking University People's Hospital
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Contacto:
- Rui Ma
- Número de teléfono: +86 18834948122
- Correo electrónico: marui_pku_ed@163.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years old.
- Diagnosed with hematological diseases and receiving triazole prophylaxis.
- Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
- Able to understand and sign the informed consent form voluntarily.
Exclusion Criteria:
- Severe liver or renal dysfunction (ALT/AST > 3×ULN, Cr > 2×ULN).
- Known allergy to amphotericin B or any component of the study drug.
- Pregnant or lactating women.
- Severe underlying diseases with expected survival < 3 months.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Amphotericin B Treatment
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Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections.
The dosage and duration will be determined based on pathogen results and clinical guidelines.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)
Periodo de tiempo: 6 weeks (42 days) after treatment initiation
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The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease.
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6 weeks (42 days) after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Survival Rate at 6 Weeks
Periodo de tiempo: 6 weeks (42 days) after treatment initiation
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Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.
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6 weeks (42 days) after treatment initiation
|
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Change in serum G test level
Periodo de tiempo: From enrollment to the end of 6-week treatment
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Change from baseline in serum (1,3)-β-D-glucan level.
Unit of measure: pg/mL.
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From enrollment to the end of 6-week treatment
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Change in serum GM test level
Periodo de tiempo: From enrollment to the end of 6-week treatment
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Change from baseline in serum galactomannan test value.
Unit of measure: ug/L.
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From enrollment to the end of 6-week treatment
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Microbiological clearance
Periodo de tiempo: From enrollment to the end of 6-week treatment
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Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture).
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From enrollment to the end of 6-week treatment
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Change in chest CT findings
Periodo de tiempo: Baseline to 6 weeks after treatment initiation
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Change from baseline in chest CT lesion characteristics (e.g., reduction in size, new lesions, complete resolution).
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Baseline to 6 weeks after treatment initiation
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Proportion of participants with treatment-emergent adverse events (AEs)
Periodo de tiempo: From first dose to 30 days after last dose.
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Proportion of participants experiencing any AE, graded according to WHO toxicity criteria (grade 3 or higher AEs leading to drug discontinuation).
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From first dose to 30 days after last dose.
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Proportion of participants discontinuing amphotericin B due to adverse events
Periodo de tiempo: During treatment period (up to 6 weeks).
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Proportion of participants who permanently stop amphotericin B because of any AE.
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During treatment period (up to 6 weeks).
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Change in serum alanine aminotransferase (ALT)
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (twice weekly).
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Change from baseline in ALT level.
Unit of measure: U/L.
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Baseline to end of treatment up to 6 weeks (twice weekly).
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Change in serum aspartate aminotransferase (AST)
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (twice weekly).
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Change from baseline in AST level.
Unit of measure: U/L.
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Baseline to end of treatment up to 6 weeks (twice weekly).
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Change in serum total bilirubin
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (twice weekly).
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Change from baseline in total bilirubin level.
Unit of measure: μmol/L.
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Baseline to end of treatment up to 6 weeks (twice weekly).
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Change in serum creatinine
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (twice weekly).
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Description: Change from baseline in serum creatinine level.
Unit of measure: μmol/L.
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Baseline to end of treatment up to 6 weeks (twice weekly).
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Change in serum electrolyte levels (potassium, sodium, calcium, magnesium)
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (twice weekly).
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Change from baseline in serum levels of potassium, sodium, calcium, and magnesium.
Each electrolyte will be reported separately as absolute change (mmol/L) from baseline.
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Baseline to end of treatment up to 6 weeks (twice weekly).
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Change in electrocardiogram (ECG) findings
Periodo de tiempo: Baseline to end of treatment up to 6 weeks (weekly).
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Change from baseline in ECG parameters (e.g., QTc interval).
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Baseline to end of treatment up to 6 weeks (weekly).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de abril de 2026
Finalización primaria (Estimado)
1 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
12 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PKUPH20260411
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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