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临床试验/ISRCTN40223079
ISRCTN40223079已完成不适用

Efficacy and safety of artesunate and sulfadoxine-pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of vivax malaria in Nangarhar, Takhar and Faryab provinces, Afghanista

World Health Organization (WHO) (Switzerland)0 个研究点目标入组 300 人开始时间: 2007年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300

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

性别
All

入选标准

  • 1. Age above 6 months
  • 2. Mono-infection with P. falciparum or P. vivax
  • 3. Parasitaemia, 1000 - 100,000 asexual forms per µl for falciparum malaria and above 250 asexual forms per µl for vivax malaria
  • 4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C
  • 5. Ability to swallow oral medication
  • 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
  • 7. Informed consent from the patient or from a parent or guardian in case of children

排除标准

  • 1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions (see Annex 1)
  • 2. Mixed or mono-infection with another Plasmodium species
  • 3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the National Center for Health Statistics [NCHS]/WHO normalised reference values, or who has symmetrical oedema involving at least the feet or who has a Mid Upper Arm Circumference [MUAC] less than 110 mm)
  • 4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS])
  • 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
  • 6. Positive pregnancy test or lactating (if adults included)

研究者

发起方
World Health Organization (WHO) (Switzerland)

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