Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 9
- 主要终点
- clearance of strongyloides infection
研究概览
简要总结
Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.
Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients older than 5 years and weighting > 15 kg
- •Current residence in non-endemic areas
- •Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at "high" titer, irrespective of results of direct tests
排除标准
- •Pregnant or lactating women
- •Subjects suffering from CNS diseases
- •Disseminated strongyloidiasis
- •Immunocompromised patients.
- •Lack of informed consent
- •Previous treatment with ivermectin (in the last year)
研究组 & 干预措施
ivermectin multiple doses
A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16
干预措施: Ivermectin (Drug)
1 dose ivermectin
A single 200 mcg/kg dose of ivermectin
干预措施: Ivermectin (Drug)
结局指标
主要结局
clearance of strongyloides infection
时间窗: 12 months
Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff
次要结局
- Patients with partial response to treatment at T 2(12 months)
- Patients with adverse reactions(From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion))
- Patients with increase in blood ALT over cutoff value(Day 17)
- Average difference in blood ALT and WBC count at day 17, compared with baseline(Day 17)
- Average difference in blood eosinophil count at T2, compared with baseline(12 months)
- All-cause mortality during the 12 months of follow-up.(12 months)
- Patients with decrease in WBC count below cutoff value(Day 17)