NCT01213433已完成4 期
Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Centre Muraz
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Treatment failure at day 28
研究概览
简要总结
This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged 6 months and above.
- •Body weight of 5 Kg and above.
- •RDT positive test.
- •Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
- •Signed (or thumb-printed whenever patients are illiterate) informed consent.
- •Patients' willingness and ability to comply with the study protocol for the duration of the study.
排除标准
- •Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
- •Known hypersensitivity to the study drugs.
- •Severe malaria.
- •Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand.
- •Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- •Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
研究组 & 干预措施
Amodiaquine+Artesunate
Experimental
干预措施: Artesunate-Amodiaquine (Drug)
结局指标
主要结局
Treatment failure at day 28
时间窗: 28 days
次要结局
未报告次要终点
研究者
研究点 (1)
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