Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Safety and efficacy of high dose primaquine
研究概览
简要总结
A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 intermediate or deficient status (G6PD activity 30-<70% or ≤30% 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
- •Age ≥18 years
- •Haemoglobin at presentation ≥8g/dl
- •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
- •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
Participants with G6PD intermediate status receive another active regimen appropriate for intermedia
G6PD activity 30-<70%
干预措施: Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days (Drug)
Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie
G6PD activity ≤30%
干预措施: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose). (Drug)
结局指标
主要结局
Safety and efficacy of high dose primaquine
时间窗: 6 Months
1. To assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity. 2. To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (\<30% activity)
次要结局
未报告次要终点