A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection
试验速览
- 阶段
- 2 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Time to resolution of viremia
研究概览
简要总结
This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.
详细描述
Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages of 15 or greater.
- •History or presence of fever (temperature > 38°C) of ≤ 72 hr duration.
- •Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination.
- •Positive NS 1 strip assay
排除标准
- •Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection
- •Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases
- •History of autoimmune, immune dysfunction disorder or taking warfarin
- •Clinical suspicion of any bacterial infection
- •Pregnancy and lactating women
研究组 & 干预措施
2 days Ivermectin
Ivermectin 200 - 400 µg/kg once daily for 2 days
干预措施: 2 days Ivermectin (Drug)
3 days Ivermectin
Ivermectin 200-400 µg/kg once daily for 3 days
干预措施: 3 days Ivermectin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to resolution of viremia
时间窗: Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.
次要结局
- Time to clearance of NS1 antigen(Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.)
- Time of subsidence of fever(From date of randomization until fever subsides)