A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,090
- 试验地点
- 4
- 主要终点
- The incidence risk of vivax parasitaemia
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question[s] it aims to answer are:
- is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)
- is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
- is the tolerability and safety of TQRevised acceptable
- is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.
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 (SDBioline, ROK))
- •Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
- •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
- •Anaemia (defined as Hb <8g/dl)
- •Pregnant or lactating females
- •Regular use of drugs with haemolytic potential
- •Known hypersensitivity to any of the study drugs.
研究组 & 干预措施
TQRevised
Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)
干预措施: Tafenoquine (Drug)
TQStandard
Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)
干预措施: Tafenoquine (Drug)
PQ7
Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)
干预措施: Primaquine (Drug)
结局指标
主要结局
The incidence risk of vivax parasitaemia
时间窗: 4 months
The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy. * compared between TQRevised and the PQ7 (non-inferiority) * compared between TQRevised and TQStandard (superiority)
次要结局
- The incidence risk of symptomatic vivax parasitaemia(6 months)
- The incidence risk of vivax parasitaemia(6 months)
- The incidence rate of vivax parasitaemia(6 months)
- The incidence rate of symptomatic vivax parasitaemia(6 months)
- The incidence risk of anaemia(7 and 14 days, 6 months)
- The incidence risk of an acute drop in Hb(7 and 14 days)
- Adverse events(42 days)
- Meth Hb concentration(day 7)