NCT04411836已完成3 期
Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 960
- 试验地点
- 6
- 主要终点
- Incidence risk any P vivax PQ7 / PQ14
研究概览
简要总结
Health care facility based, randomized, controlled, open label, superiority trial with 3 arms
详细描述
- To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days).
- To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen.
- To assess the safety of tafenoquine compared to the high and low dose primaquine regimens.
- To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Danger signs or symptoms of severe malaria
- •Anaemia (defined as Hb <8g/dl)
- •Pregnant or lactating females
- •Known hypersensitivity to any of the study drugs
- •Regular use of drugs with haemolytic potential
研究组 & 干预措施
PQ Intervention
Experimental
Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
干预措施: Primaquine (Drug)
TQ Intervention
Experimental
Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)
干预措施: Tafenoquine (Drug)
结局指标
主要结局
Incidence risk any P vivax PQ7 / PQ14
时间窗: 6 months
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).
次要结局
- Incidence risk any P vivax PQ14 / TQ(6 months)
- Incidence risk any P vivax PQ7 / TQ(6 months)
- Incidence risk symptomatic P vivax TQ / PQ14(6 months)
- Incidence risk any P vivax PQ7 / PQ14(6 months)
研究者
研究点 (6)
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