Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Incidence risk of any P. vivax parasitaemia at day 63
研究概览
简要总结
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
详细描述
Plasmodium vivax forms dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, direct and indirect mortality, and are the most important source of onward transmission of the parasite. In co-endemic areas, there is a very high risk (up to 50%) of patients representing with P. vivax malaria following treatment of P. falciparum. Hence, in co-endemic regions there is a strong rationale for eradicating P. vivax hypnozoites from the liver in patients presenting with uncomplicated P. falciparum infections.
The recently completed multicentre IMPROV study compared the efficacy of a 7 day primaquine regimen (1.0 mg/kg/day for 7 days) with a 14 day regimen (0.5 mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5-fold more efficacious at reducing P. vivax recurrence than the control.
This study is designed as a multicentre randomized, open label trial to compare the safety and efficacy of a high dose PQ treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •P. falciparum mono-infection
- •Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- •Age >1 years (≥ 18 years at the Ethiopia site)
- •G6PD normal as defined by the Biosensor (SD Biosensor, ROK) at ≥70% of the adjusted male median (AMM) for each site
- •Written informed consent
- •Able to comply with all study procedures and timelines
排除标准
- •General danger signs or symptoms of severe malaria
- •Anaemia, defined as Hb <8g/dl
- •Pregnant women as determined by Urine β-HCG pregnancy test
- •Breast feeding women
- •Known hypersensitivity to any of the drugs given
- •Regular use of drugs with haemolytic potential
- •Blood transfusion within the last 4 months
研究组 & 干预措施
PQ7
high dose primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)
干预措施: primaquine (Drug)
结局指标
主要结局
Incidence risk of any P. vivax parasitaemia at day 63
时间窗: 63 days
The incidence risk of any P. vivax parasitaemia at day 63
次要结局
- Incidence risk of symptomatic P. vivax parasitaemia at day 63(63 days)
- Incidence risk of all any P. vivax parasitaemia at day 28 and 42(28 and 42 days)
- proportion of patients vomiting any of their PQ doses within 1 hour of administration(7 days)
- proportion of patients vomiting their medication within 1 hour of administration(1 hour)
- • The incidence risk of ≥25% fall in haemoglobin since baseline with and without hemoglobinuria at day 3 and day 7(7 days)
- proportion of adverse events and serious adverse events(63 days)
- Incidence risk of any P. falciparum malaria at day 28, 42 and 63(28/42/63 days)
- incidence risk of severe anaemia (Hb<5g/dl) and moderately severe anaemia (<7g/dl) and/or the risk for blood transfusion between day 3 and 7(7 days)
- The incidence risk of ≥25% fall in haemoglobin to under 7g/dl with and without hemoglobinuria at day 3 and day 7(day 7)
- Parasite clearance on day 1, 2 and 3(3 days)
- Incidence risk of P. falciparum gametocytaemia between day 7 and 63(63 days)
- Fever clearance on day 1, 2 and 3(3 days)