Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Haemoglobin concentration relative to baseline value
研究概览
简要总结
The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male gender
- •Age ≥18 years and ≤45 years
- •P. falciparum parasitaemia at any density
- •G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50)
- •G6PD normal activity by Beutler Fluorescent Spot test for control groups (N=20)
- •Informed consent by participant
排除标准
- •Enrolled in another clinical trial
- •Fever >37.5°C (tympanic) or history of fever in the last 24 hours
- •Evidence of severe illness / danger signs or active infection other than malaria
- •Known allergy to study medications
- •Hb <11 g/dL
- •Antimalarials taken within the last 2 weeks
- •PQ taken within the last 4 weeks and blood transfusion within the last 90 days
- •Non-falciparum malaria co-infection
- •Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, , nalidixic acid, ciprofloxacin, , methylene blue, toluidine blue phenazopyridine and co-trimoxazole.
- •History of severe chronic illness
研究组 & 干预措施
G6PD-deficient 0.4 mg/kg PQ + AL
G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
干预措施: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine (Drug)
G6PD normal 0.4 mg/kg PQ + AL
G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine
干预措施: Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine (Drug)
G6PD deficient 0.25 mg/kg PQ + AL
G6PD deficient males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
干预措施: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine (Drug)
G6PD deficient receiving AL only
G6PD deficient males receiving Artemether-Lumefantrine (AL) combination
干预措施: Artemether-Lumefantrine (AL) combination (Drug)
G6PD normal 0.25 mg/kg PQ + AL
G6PD normal males receiving Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine
干预措施: Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine (Drug)
结局指标
主要结局
Haemoglobin concentration relative to baseline value
时间窗: 28 days
Haemoglobin concentration relative to baseline value
次要结局
- Gametocyte clearance time(14 days)