Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With Visceral Leishmaniasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- The primary efficacy variable is parasitological clearance with no relapse at 6 months post treatment (ie definitive cure) assessed by clinical status and confirmed by splenic or bone marrow aspiration.
研究概览
简要总结
This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults and children aged 4 years or older with no upper age limit (in accordance with manufacturer's instructions)
- •Acute, symptomatic, VL proven by parasitological examination of splenic aspirate (or bone marrow aspirate) with initial parasite index of at least 2+
- •Haemoglobin >4g/dL
- •Fever for more than 2 weeks
- •Living within reachable distance of the trial site to enable attendance for follow-up visits
- •Written informed consent to participate (for children, by parent or guardian)
- •HIV negative status
排除标准
- •Patients 'in extremis' with signs/symptoms indicative of severe VL
- •Patients who have received any anti-leishmanial treatment within the last 6 months
- •Patients who have received any investigational (unlicensed) drugs during 6 months before recruitment
- •Known underlying chronic disease, such as severe cardiac, pulmonary, renal, or hepatic impairment.
- •Renal function tests (serum creatinine) outside the normal range
- •Liver function tests more than 3 times the normal range at study entry
- •Platelet count less than 40,000/ mm3
- •Known alcohol abuse
- •Pregnancy or lactation
- •Concomitant acute drug usage for malaria and bacterial infection, pneumonia within last 7 days
- •Known hypersensitivity to AmBisome or amphotericin B
- •Any other condition which may invalidate the trial
研究组 & 干预措施
Ambisome control:
Ambisome, Total dose 21.0 mg given as 7 x 3mg on days 1,2,3,4,5, and 14 and 21
干预措施: Liposomal amphotericin B (Ambisome) (Drug)
Ambisome test
Single dose Ambisome in sequence(7.5 / 10.0/ 12.5 / 15.0mg)
干预措施: Liposomal amphotericin B (Ambisome) (Drug)
结局指标
主要结局
The primary efficacy variable is parasitological clearance with no relapse at 6 months post treatment (ie definitive cure) assessed by clinical status and confirmed by splenic or bone marrow aspiration.
时间窗: at 6 months post treatment
次要结局
- Parasitological clearance at day 30.(Day 30)