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临床试验/NCT00623155
NCT00623155已完成不适用

Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management

University of Bamako1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2002年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
262
试验地点
1
主要终点
incidence rate of clinical malaria

研究概览

简要总结

Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6 months to 10 years
  • Agree to seek initial medical care for all medical illness in the study clinic during the study period
  • Written informed consent by a parent or legal garden,
  • No plan to travel for a long time during the study period.

排除标准

  • History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
  • Chronic illness or symptomatic malaria at the time of enrollment

研究组 & 干预措施

2

Experimental

Test group

干预措施: Seasonal IPT in children - Sulfadoxine-pyrimethamine (Drug)

结局指标

主要结局

incidence rate of clinical malaria

in vivo adequate clinical and parasitological response of P. falciparum to SP

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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