NCT06756191尚未招募4 期
Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis
Bin Cao0 个研究点目标入组 312 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 312
- 主要终点
- 4-week favourable response rate
研究概览
简要总结
Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days.
- •Patients who have documented allergies to azoles or amphotericin B regimens
- •Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN).
- •Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis.
- •Patients who have experienced a myocardial infarction or cerebral infarction.
- •Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment.
- •Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.
研究组 & 干预措施
Single drug group
Active Comparator
Liposomal amphotericin B (AmBisome®)
干预措施: Liposomal Amphotericin B (Drug)
Combination therapy
Experimental
Liposomal amphotericin B (AmBisome®) combination with Isavuconazole
干预措施: Combination therapy group (Drug)
结局指标
主要结局
4-week favourable response rate
时间窗: 4 week
The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT.
次要结局
- 12-week mortality(12 week)
- 24-week mortality(24 week)
- Frequency of adverse events(4 week)
研究者
Bin Cao
Professor
Capital Medical University
相似试验
已完成
2 期
Amphotericin Versus Posaconazole for Pulmonary MucormycosisMucormycosis; Pulmonary (Etiology)NCT05468372Post Graduate Institute of Medical Education and Research, Chandigarh82
招募中
2 期
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary InfectionLung DiseasesXenopi MycobacteriumNCT06585020Centre Hospitalier Universitaire, Amiens190
暂停
1 期
A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary InfectionDrug-resistantNCT04544215Ruijin Hospital60
已完成
3 期
Liposomal Amphotericin in Disseminated LeishmaniasisDisseminated LeishmaniasisNCT02025491Hospital Universitário Professor Edgard Santos20
已完成
不适用
Sublingual Immunotherapy in Children With Allergic RhinitisAllergic RhinitisNCT01506843Federal University of Uberlandia122