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临床试验/PACTR201905783261453
PACTR201905783261453已完成未知

Efficacy and parasite clearance time with artemether-lumefantrine for uncomplicated falciparum malaria in children of Nchelenge District, Zambia

Macha Research Trust0 个研究点目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
1 Month(s) 至 23 Month(s)(—)
性别
All

入选标准

  • Age between 6 months and 5 years (i.e. up to 59 months of age)
  • Mono-infection with P. falciparum detected by microscopy
  • Parasitaemia of 2,000 to 200,000 /µl asexual forms
  • Presence of axillary or tympanic temperature = 37.5 °C or oral or rectal temperature of = 38 °C, or history of
  • Ability to swallow oral medication
  • Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
  • Written informed consent from a parent or guardian

排除标准

  • Presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO as adapted to the clinic setting
  • Mixed or mono-infection with another Plasmodium species detected by microscopy
  • Presence of severe malnutrition defined as a child whose growth (wt for age) is below –3 Z-score
  • Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS)
  • Regular medication, which may interfere with antimalarial pharmacokinetics
  • History of hypersensitivity reactions or contraindications to artemether-lumefantrine

研究者

发起方
Macha Research Trust

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