An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria (PRIMUS)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,019
- 试验地点
- 5
- 主要终点
- Incidence risk of any recurrent vivax parasitaemia within 4 months.
研究概览
简要总结
Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •P. vivax peripheral parasitaemia as determined by microscopy
- •G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))
- •Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,
- •Age ≥5 years
- •Bodyweight ≥14kg
- •Living in the study area and willing to be followed-up for six months
排除标准
- •Signs or symptoms of severe malaria,
- •Anaemia (defined as Hb <8g/dl) and measured by the Standard G6PD
- •Pregnant or lactating
- •Blood transfusion within the preceding four months
- •Regular or recent use (last month) of tafenoquine, primaquine or dapsone
- •Known hypersensitivity to any of the study drugs
研究组 & 干预措施
High-dose Short-course Primaquine (PQ7)
Participants in this arm will receive a high-dose, short-course primaquine regimen (PQ7), consisting of a total dose of 7 mg/kg administered as 1 mg/kg once daily in the morning for 7 days (Day 0-6). A matching placebo will be given in the evening on the first three days (Day 0-2).
干预措施: High dose ultra short Primaquine (Drug)
High-dose Short-course Primaquine (PQ7)
Participants in this arm will receive a high-dose, short-course primaquine regimen (PQ7), consisting of a total dose of 7 mg/kg administered as 1 mg/kg once daily in the morning for 7 days (Day 0-6). A matching placebo will be given in the evening on the first three days (Day 0-2).
干预措施: Placebo (Other)
High dose ultra- short course Primaquine (PQ 3.5)
Participants in this arm will receive a high-dose, ultra-short primaquine regimen (PQ3.5), consisting of a total dose of 7 mg/kg administered as 1 mg/kg twice daily for 3.5 days (Day 0-2 morning and evening doses, and Day 3 morning dose). A matching placebo will be given as the morning dose on Days 4-6.
干预措施: High dose ultra short Primaquine (Drug)
High dose ultra- short course Primaquine (PQ 3.5)
Participants in this arm will receive a high-dose, ultra-short primaquine regimen (PQ3.5), consisting of a total dose of 7 mg/kg administered as 1 mg/kg twice daily for 3.5 days (Day 0-2 morning and evening doses, and Day 3 morning dose). A matching placebo will be given as the morning dose on Days 4-6.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence risk of any recurrent vivax parasitaemia within 4 months.
时间窗: 4 Months
The incidence risk (time to first event) of any recurrent P. vivax parasitaemia within 4 months as determined by microscopy
次要结局
- Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment.(0-14 days)
- The incidence risk of any P. vivax parasitaemia within 6 months.(6 months)
- Incidence of moderate anaemia within 14 days after starting primaquine(0-14 days)
- Incidence of severe anaemia within 14 days after starting Primaquine(0-14 days)
- • The proportion of patients requiring blood transfusion within the 6 months follow up period.(6 months)
- The incidence risk of symptomatic P. vivax parasitaemia within 4 months.(4 months)
- Proportion of adverse events within 14 days.(14 days)
- The number and proportion of serious adverse events.(6 Months)