Safety and Effectiveness of Short-course AmBisome in the Treatment of Post-Kala-azar Dermal Leishmaniasis (PKDL): a Prospective Cohort Study in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 主要终点
- Final outcome
研究概览
简要总结
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
详细描述
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)
排除标准
- •PKDL and concurrent VL
- •Prior treatment for PKDL
- •On medication with a side effect profile overlapping with that of AmBisome
- •A known hypersensitivity to AmBisome
- •Pregnant and lactating women,
- •Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine > 1.3 mg/dL)
- •Serum potassium <3.5mmol/L at baseline
研究组 & 干预措施
Cohort treated with AmBisome 15 mg/kg
280 patients, receiving AmBisome
干预措施: AmBisome (Drug)
结局指标
主要结局
Final outcome
时间窗: 12 months
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
次要结局
- Hypokalaemia(7 weeks)
- Safety(7 weeks)