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临床试验/NCT00294580
NCT00294580已完成4 期

Comparison of Two Strategies for Control of Malaria Within A Primary Health Care Programme in the Gambia

Imperial College London1 个研究点 分布在 1 个国家目标入组 2,253 人开始时间: 2006年2月22日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
2,253
试验地点
1
主要终点
Mortality

研究概览

简要总结

A trial was conducted in the 1980s to compare two strategies for control of malaria in young children aged 3-59 months: treatment with chloroquine versus treatment combined with fortnightly chemoprophylaxis with Maloprim. The impact on mortality and morbidity was assessed at the time, and their cognitive abilities and educational outcomes were assess 14 years later in 2001. The hypothesis was that the chemoprophylaxis would reduce morbidity and mortality and would improve cognitive abilities and educational outcomes in the long term

详细描述

Two drug strategies for the control of malaria in children aged 3-59 months have been compared in a rural area of The Gambia - treatment of presumptive episodes of clinical malaria with chloroquine by village health workers, and treatment combined with fortnightly chemoprophylaxis (pyrimethamine/dapsone) which was also given by village health workers. Treatment alone did not have any significant effect on mortality or morbidity from malaria. In contrast, treatment and chemoprophylaxis reduced overall mortality in children aged 1-4 years, mortality from probable malaria, and episodes of fever associated with malaria parasitaemia. A high level of compliance with chemoprophylaxis was obtained and no harmful consequences of chemoprophylaxis were observed. Chemoprophylaxis was offered to all children at the end of the trial.

14 years after the end of the trial, participants cognitive abilities and educational attainment were assessed. Associations have been found between malaria infection and poor cognitive ability but causality has not yet been demonstrated through preventative trials and the long-term impact of malaria has not been investigated. 1190 children who had participated in the original trial for at least one year were targetted for follow-up. 579 were traced. Those who had received chemoprophylaxis attended school for 0.52 years more than the placebo group (p=.069). There was no overall effect on cognitive abilities but there was a significant treatment effect for cohorts that had not received chemoprophylaxis at the end of the trial or who had received less than one year of post-trial prophylaxis

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
Double

入排标准

年龄范围
3 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • For original trial: Children aged 3-59 months present in participating villages
  • For follow-up: Children who were in original trial for at least 1 year.

排除标准

  • For original trial: None
  • For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests

结局指标

主要结局

Mortality

Episodes of Fever Associated with Malaria Parasitaemia

Cognitive Abilities in late adolescence

Educational Attainment (Years spent at school)

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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