A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
研究概览
简要总结
This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
- •Age >5 years
- •Weight >5kg
- •Written informed consent
- •Living in the study area and willing to be followed for 4 months
排除标准
- •General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)
- •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
- •Living in the same household as an individual enrolled into the study in the last 14 days
研究组 & 干预措施
Supervised primaquine arm
Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure. Supervision of primaquine is done on alternate days at home (attended by a home visitor) or at the health centre.
干预措施: Supervised primaquine treatment (Drug)
Unsupervised primaquine arm
Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure for self administration.
干预措施: Unsupervised primaquine treatment (Drug)
结局指标
主要结局
The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.
时间窗: 4 months
次要结局
- The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.(4 months)
- The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.(4 months)
- The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.(4 months)
- The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax.(4 months)
- The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients(4 months)
- The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted(1 year)
- Socio-economic factors for adherence to primaquine treatment(1 year)
- The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.(4 months)
- The incidence risk of patent or sub-microscopic P. vivax malaria over 4 months in patients enrolled with malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)(4 months)