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临床试验/NCT01454752
NCT01454752已完成不适用

Intermittent Parasite Clearance (IPC) in Schools: a Randomised Double-blind Placebo-controlled Trial of the Impact of IPC on Malaria, Anaemia and Cognition Amongst School Children in Kedougou, Senegal

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 860 人开始时间: 2011年11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
860
试验地点
1
主要终点
Prevalence of malaria parasitaemia

研究概览

简要总结

Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria infection, clinical illness and death. By the time they reach school, many children have already acquired some clinical immunity and the ability to limit parasite growth, and thus most infections are asymptomatic and will go undetected and untreated. Asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom, and interventions aiming to reduce asymptomatic parasite carriage may bring education, as well as health, benefits.

Intermittent parasite clearance (IPC) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes, and may usefully supplement the community-distribution of insecticide-treated nets (ITNs) in countries with a policy of universal coverage of nets.

This study seeks to establish whether intermittent parasite clearance undertaken once a year at the end of the malaria transmission season can reduce malaria parasite carriage and anaemia amongst school-going children already using insecticide-treated nets, and its consequent impact on school attendance and performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes in areas of seasonal malaria transmission.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • enrolled in participating elementary schooled
  • provision of parental consent

排除标准

  • lack of consent
  • chronic conditions which limit regular school attendance
  • clinical malaria on the day of scheduled treatment (as defined as febrile, with a positive result in a rapid diagnostic test for malaria).

研究组 & 干预措施

Intermittent parasite clearance

Active Comparator

Children sleeping under a long-lasting insecticidal net (LLIN) receive an additional intermittent preventive treatment for clearance of asymptomatic malaria infection given once a year at the end of the malaria transmission season

干预措施: Intermittent parasite clearance (Drug)

Control

Placebo Comparator

Children sleeping under a long-lasting insecticidal net (LLIN) receive placebo

干预措施: Placebo (Other)

结局指标

主要结局

Prevalence of malaria parasitaemia

时间窗: 8 weeks after treatment (February 2012)

Prevalence of anaemia (Haemoglobin<11 g/dL)

时间窗: 8 weeks after treatment (February 2012)

次要结局

  • Cognitive performance in tests of sustained attention(8 weeks after treatment (February 2012))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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