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临床试验/NCT00142246
NCT00142246已完成3 期

Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 6,758 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
6,758
试验地点
1
主要终点
Prevalence of anaemia (Hb <112g/L)

研究概览

简要总结

This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.

详细描述

Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding & Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.

The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.

The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.

Schools are randomly allocated to one of two arms:

  • Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
  • Control schools: mass treatment with anthelminthics only

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Enrolled in primary school, and attending regularly
  • Enrolled in nursery or classes 1-7
  • Informed consent from parent or guardian

排除标准

  • Enrolled in primary class 8
  • Haemoglobin level below 70g/L at baseline
  • History of reaction to sulfa drugs (e.g. fansidar, septrin)
  • History of severe skin reaction to any drug
  • Withdrawal criteria:
  • Withdrawal of parental consent
  • Haemoglobin level falling below 70g/L
  • Severe adverse reaction to treatment

研究组 & 干预措施

1

Experimental

Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)

干预措施: Intermittent preventive treatment (SP and amodiaquine) (Drug)

2

Placebo Comparator

Dual placebo comparator

干预措施: Placebo (Other)

结局指标

主要结局

Prevalence of anaemia (Hb <112g/L)

时间窗: March 2006

次要结局

  • Prevalence of Plasmodium falciparum parasitaemia(March 2006)
  • Mean haemoglobin(March 2006)
  • Sustained attention(March 2006)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Greenwood

Professor

London School of Hygiene and Tropical Medicine

研究点 (1)

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