Evaluation of Weekly Tafenoquine (SB 252263 / WR 238605) Compared to Placebo for Chemosuppression of Plasmodium Falciparum in Western Kenya
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 主要终点
- Prophylactic outcome.
研究概览
简要总结
This study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of WR 238605, a new primaquine analog, compared to placebo as chemosuppression of P. falciparum malaria in Nyanza Province, western Kenya.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy subjects (male or female)
- •Age of 18-55 years
- •Residing in one of the study villages of the Nyanza Province for the entire study
排除标准
- •Any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result.
- •Female subjects who were pregnant (Positive serum / plasma -HCG as tested within 48 hours of first drug administration).
- •Use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation.
- •Clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count.
- •Known hypersensitivity to any study drug.
- •Unwilling to remain in area and report for drug administration and blood drawing during the duration of the study.
- •Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency.
研究组 & 干预措施
High weekly dose
Loading with tafenoquine to 400 mg base for 3 days followed by tafenoquine 400 mg base weekly.
干预措施: Tafenoquine (Drug)
Load only
Loading with tafenoquine 400 mg base for three days followed by placebo weekly.
干预措施: Tafenoquine (Drug)
Low weekly dose
Loading with tafenoquine 200 mg base for 3 days followed by tafenoquine 200 mg weekly.
干预措施: Tafenoquine (Drug)
Placebo
Loading with placebo for 3 days followed by placebo once weekly.
干预措施: Placebo (Other)
结局指标
主要结局
Prophylactic outcome.
时间窗: 13 Weeks
Thick blood films were stained with Giemsa stain and malaria parasite counts determined by counting the number of asexual parasites per 200 white blood cells. A blood slide was not considered negative until an examination of 200 oil immersion fields showed no parasites.
次要结局
- Prophylactic outcome after 7 weeks(7 Weeks)
- Prophylactic outcome after 10 weeks(10 Weeks)