NCT07060794尚未招募4 期
Tafenoquine and ACTs (TADORE- Plus)
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 507
- 主要终点
- incidence risk (time to first event) of any P. vivax parasitaemia
研究概览
简要总结
A trial designed to determine whether there is a clinically significant drug-drug interaction of tafenoquine with DHA-piperaquine or artesunate-pyronaridine using a control arm with radical cure given at the end of follow up (delayed radical cure).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •P. vivax peripheral parasitaemia (mono-infection)
- •G6PD normal status (G6PD activity ≥70% of the adjusted male median
- •as determined by the Standard G6PD (SD Biosensor, ROK))
- •Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
- •Age ≥18 years
- •Haemoglobin at presentation ≥8g/dl
- •Written informed consent.
- •Living in the study area and willing to be followed for six months
排除标准
- •Danger signs or symptoms of severe malaria
- •Pregnant or lactating females
- •Regular use of drugs with haemolytic potential
- •Known hypersensitivity to any of the study drugs
- •History of any psychiatric disorder
研究组 & 干预措施
Tafenoquine plus artesunate-pyronaridine
Experimental
干预措施: Tafenoquine plus Artesunate-pyronaridine (Drug)
Tafenoquine plus DHA-Piperaquine
Experimental
干预措施: Tafenoquine plus DHA-Piperaquine (Drug)
DHA-Piperaquine
No Intervention
结局指标
主要结局
incidence risk (time to first event) of any P. vivax parasitaemia
时间窗: 4 months
次要结局
未报告次要终点
研究者
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