跳至主要内容
临床试验/EUCTR2012-001333-14-Outside-EU/EEA
EUCTR2012-001333-14-Outside-EU/EEA进行中(未招募)不适用

A randomized, investigator-blinded, multicenter, parallel group study to compare efficacy, safety and tolerability of Coartem® dispersible tablet formulation vs. Coartem® 6-dose crushed tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants and children

ovartis Pharma AG0 个研究点目标入组 890 人开始时间: 2012年3月9日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
890

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • male or female infants and children =12 years of age
  • (Sites will strive to recruit patients across the entire age range, but based on cultural considerations some may need to restrict their target population to female infants and children =7 years of age, or to male or female infants and children =5 years)
  • body weight of =5 kg and <35 kg,
  • with a confirmed diagnosis of uncomplicated malaria caused by the Plasmodium falciparum parasite
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 899
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • complicated malaria
  • persistent vomiting
  • malaria due to other parasites than Plasmodium falciparum
  • antimalarial treatment received in the past 2 weeks
  • known chronic disease (e.g. positive HIV status, severe cardiac, renal, or hepatic disease)

研究者

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