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临床试验/NCT01133314
NCT01133314已完成不适用

The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2

Bandim Health Project1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Percentage of children treated for malaria with a parasitological confirmed malaria.

研究概览

简要总结

The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.

详细描述

Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:

All children getting the clinical diagnosis of malaria will be registered and basic information collected.

All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.

The study does not interfere in the routine treatment of the health staff. None of the children will be followed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

排除标准

  • Children where the parents do not accept to participate in the study.

结局指标

主要结局

Percentage of children treated for malaria with a parasitological confirmed malaria.

时间窗: 6 weeks

The blood samples will be analysed for parasites at the end of the study. The results do not have any impact on the treatment of the children.

次要结局

  • Percentage of the parasites with mutations coding for resistance to antimalarials.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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