跳至主要内容
临床试验/NCT00289250
NCT00289250已完成3 期

Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial

London School of Hygiene and Tropical Medicine2 个研究点 分布在 2 个国家目标入组 360 人开始时间: 2001年5月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
360
试验地点
2
主要终点
Presence of gametocytes 7 days after treatment

研究概览

简要总结

Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.

详细描述

Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • P.falciparum parasitaemia above 20/uL
  • Resident in one of the four study villages

排除标准

  • Any other sign of clinical malaria
  • Pregnancy
  • Weight <5kg
  • History of hypersensitivity to any of the study drugs
  • Treatment with any of the study drugs in the last 4 weeks

结局指标

主要结局

Presence of gametocytes 7 days after treatment

次要结局

  • Presence of gametocytes 56 days after treatment
  • Asexual parasitaemia 14 days after treatment

研究者

研究点 (2)

Loading locations...

相似试验