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临床试验/PACTR202309773069812
PACTR202309773069812已完成Unknown

Therapeutic efficacy and safety of Artemether-Lumefantrine combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria at Teda Health Center, Northwest Ethiopia

niversity of Gondar0 个研究点目标入组 88 人开始时间: 2023年7月6日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
88

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
0 Month(s) 至 23 Month(s)(—)
性别
All

入选标准

  • Age 6 months–70 years
  • No history of malaria treatment within the last 28 days
  • Permanent resident within 5 km radius from the HC
  • Plasmodium falciparum infection confirmed by microscopy
  • Parasitaemia level of 1,000/µl-100,000/µl asexual forms
  • Presence of axillary temperature = 37.5 °C or history of fever during the past 24hs
  • Ability to swallow oral medication
  • Ability to comply to the study protocol

排除标准

  • Presence of complication or danger signs of severe malaria
  • Presence of severe malnutrition (body mass index (BMI) <18.5 kg/m2 or z-score <3)
  • Presence of known diseases other than malaria (typhoid fever, typhus, hepatitis, HIV/AIDS, pneumonia and tuberculosis)
  • Regular medications that may interfere with AL pharmacokinetics (antiretroviral, ketoconazole and rifampicin)
  • History of hypersensitivity reactions to AL
  • Pregnancy or lactating women
  • Vomited twice during drug administration

研究者

发起方
niversity of Gondar

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