Study to Determine the Efficacy of Artesunate-mefloquine Combination Therapy for the Treatment of Uncomplicated P. Falciparum Malaria in Thailand
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Parasite clearance rate
研究概览
简要总结
The purposes of this study is to determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria.
详细描述
Project Summary
Objectives
Primary Objective
- To determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thai or non-Thai, otherwise healthy, male or female, aged from 5 years to 65 years inclusive
- •Acute uncomplicated P. falciparum malaria monoinfection, confirmed by positive blood smear
- •Asexual P. falciparum parasitaemia of 1,000 to 200,000 parasites/µL, confirmed on a thin or thick blood film
- •Fever defined as ≥ 38.0°C tympanic temperature (or equivalent) or a history of fever within the last 24 hours
- •Willingness to participate in the study as evidenced by written informed consent from the subject or parent/guardian (for children), and by assent (for children)
- •Exclusion criteria:
- •Severe malaria as defined by WHO criteria (reference WHO 2012)
- •Inability to eat or drink, inability to tolerate oral antimalarial medication, recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand
- •Mixed species asexual stage malaria infection as determined by microscopy
- •Recent antimalarial treatment, defined as a clear history of any antimalarial medication taken within the previous 7 days; or a clear history of mefloquine within previous 4 weeks
- •History of splenectomy
- •Pregnancy or nursing mother
- •Known hypersensitivity to artesunate, mefloquine or primaquine
- •PI determines that it is in the best interests of the subject not to participate in the trial
排除标准
- 未提供
研究组 & 干预措施
artesunate/mefloquine (AS/MQ)
The antimalarial drug regimen being evaluated is: artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours; plus mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours; plus primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours
干预措施: Artesunate/mefloquine (AS/MQ) (Drug)
结局指标
主要结局
Parasite clearance rate
时间窗: one year
Parasite clearance rate as defined by the slope of the linear portion of the logarithm parasite clearance curve using microscopy to determine parasitemia
次要结局
- Number of patients with prolonged parasite clearance times, adequate drug levels and positive molecular markers of parasite resistance.(one year)