Набор скоро начнётся NCT07559032

Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients

Без фазы С лечением Invasive Fungal Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Amphotericin B.
Кому может быть актуально: Состояния в реестре: Invasive Fungal Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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: 1. What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis? 2. What medical problems do participants have when taking amphotericin B? 3. What is the 6-week (42-day) overall survival rate after starting treatment? This is a single-arm, prospective study. Participants will: 1. Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks. 2. Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks. 3. Have safety monitoring including liver and kidney function, electrolytes, and ECG. 4. Be followed for treatment response and survival.

Вмешательства

Препарат Amphotericin B
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.

Первичные конечные точки

Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days) [Срок оценки: 6 weeks (42 days) after treatment initiation]

Вторичные конечные точки (12)

Overall Survival Rate at 6 Weeks [Срок оценки: 6 weeks (42 days) after treatment initiation]
Change in serum G test level [Срок оценки: From enrollment to the end of 6-week treatment]
Change in serum GM test level [Срок оценки: From enrollment to the end of 6-week treatment]
Microbiological clearance [Срок оценки: From enrollment to the end of 6-week treatment]
Change in chest CT findings [Срок оценки: Baseline to 6 weeks after treatment initiation]
Proportion of participants with treatment-emergent adverse events (AEs) [Срок оценки: From first dose to 30 days after last dose.]
Proportion of participants discontinuing amphotericin B due to adverse events [Срок оценки: During treatment period (up to 6 weeks).]
Change in serum alanine aminotransferase (ALT) [Срок оценки: Baseline to end of treatment up to 6 weeks (twice weekly).]
Change in serum aspartate aminotransferase (AST) [Срок оценки: Baseline to end of treatment up to 6 weeks (twice weekly).]
Change in serum total bilirubin [Срок оценки: Baseline to end of treatment up to 6 weeks (twice weekly).]
Change in serum creatinine [Срок оценки: Baseline to end of treatment up to 6 weeks (twice weekly).]
Change in serum electrolyte levels (potassium, sodium, calcium, magnesium) [Срок оценки: Baseline to end of treatment up to 6 weeks (twice weekly).]

Критерии участия

Критерии включения

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.