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临床试验/NCT01213433
NCT01213433已完成4 期

Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Centre Muraz1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年10月最近更新:
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

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

发起方
Centre Muraz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tinto Halidou

PharmD, PhD

Centre Muraz

研究点 (1)

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