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临床试验/PACTR201611001859416
PACTR201611001859416已完成未知

A randomised controlled trial to investigate the efficacy, safety and tolerability of adding a single low primaquine dose to artemether-lumefantrine for the treatment of symptomatic uncomplicated Plasmodium falciparum malaria

niversity of Cape Town0 个研究点目标入组 140 人开始时间: 2016年11月11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
140

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
2 Year(s) 至 100 Year(s)(—)
性别
All

入选标准

  • Plasmodium falciparum positive by RDT
  • Age > 2 years
  • Weight over 10 kg
  • Prescribed artemether-lumefantrine according to standard practice
  • Informed consent (by legally acceptable representative if under 18 years of age)
  • Assent in children aged 7 and above
  • Intention to remain in the study area for the duration of the follow-up period

排除标准

  • Evidence of severe illness/ danger signs
  • Known allergy to study medications
  • Medical history of haemolysis, rheumatoid arthritis, lupus erythematosus or cardiac disease
  • In patients receiving concurrently other drugs that are cause hemolysis, bone marrow suppression or QTc interval prolongation
  • Hb < 7 g/dL
  • A decrease in Hb of > 2 g/dL between day 0 and day 3 prior to primaquine dose
  • Currently menstruating
  • Pregnant or breastfeeding
  • History of any antimalarials (including primaquine) taken within the last 4 weeks
  • Blood transfusion within the last 90 days

研究者

发起方
niversity of Cape Town

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