Short Course Radical Cure of P.Vivax in Nepal- a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Incidence Risk of P. vivax relapse at month 6
研究概览
简要总结
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
详细描述
Plasmodium vivax is associated with recurrent infections weeks or months following the acute infection due to reactivation of dormant liver stages. Recurrent infections can be associated with a febrile illness, 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 PQ regimen (1.0mg/kg/day for 7 days) with a 14 day regimen (0.5mg/kg/day for 14 days). The 7 day PQ regimen was non-inferior to the 14 day regimen and 5 times more efficacious at reducing P.vivax recurrence than the control.
This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in G6PD normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.
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 and/or vivax infection
- •Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- •Age >1 years
- •G6PD normal by Rapid Diagnostic Test (RDT) as per national guidelines
- •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
(P.f)
patients with falciparum malaria will receive artemether-lumefantrine (AL) twice daily over three days plus a low dose course of primaquine (PQ) (3.5mg/kg total dose) given 7 days during schizontocidal treatment
干预措施: primaquine (Drug)
(P.v)
patients with vivax malaria will receive chloroquine (CQ) daily for three days plus a low dose course of PQ (3.5mg/kg total dose) given over 7 days during schizontocidal treatment.
干预措施: primaquine (Drug)
结局指标
主要结局
Incidence Risk of P. vivax relapse at month 6
时间窗: 6 months
The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax and P. falciparum infection.
次要结局
- The incidence risk of symptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection(Day 28)
- The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. vivax(6 months)
- The incidence risk of all (symptomatic and asymptomatic) P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection(Day 28)
- The incidence risk of symptomatic P. vivax malaria at month 6 in patients enrolled with P. falciparum(6 month)
- The incidence risk of asymptomatic P. vivax malaria at day 28 in patients enrolled with P. falciparum and vivax malaria infection(Day 28)