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临床试验/NCT01713517
NCT01713517Unknown4 期

Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan

London School of Hygiene and Tropical Medicine3 个研究点 分布在 1 个国家目标入组 28,000 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
4 期
入组人数
28,000
试验地点
3
主要终点
Malaria Incidence

研究概览

简要总结

The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

详细描述

The study will assess the impact that insecticide resistance has on the effectiveness of malaria vector control tools LLIN and IRS. This is done by a cluster randomised trials of universal coverage LLINs versus universal coverage LLINs in combination with IRS, with levels of baseline insecticide resistance in the main vector balanced between the two study arms. In each cluster resistance to the insecticide used on LLINs is monitored, and malaria incidence is estimated from cluster specific cohorts of children followed up over the duration of the study. Resistance impact will be assessed from the ratio of incidence rates in clusters with high compared to those with low resistance and from a continuous measure of resistance expressed as percentage loss of mosquito mortality when exposed to insecticide in standardised WHO tests. Resistance mechanisms will be studied in subsets of study clusters.

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
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

  • Children older than 6 months and younger than 10 years in approximately 100 randomly selected households in all 140 study clusters selected in the four study areas

排除标准

  • Children living in households within 1 km from the edge of a neighbouring cluster (the buffer zone)

结局指标

主要结局

Malaria Incidence

时间窗: 3 years

Infection with malarial parasites determined by rapid diagnostic tests/microscopy in cohort members who report or have fever (\>37.5C)

次要结局

  • Prevalence of P.falciparum Infection(3 years)
  • Entomological Innoculation rate(Average for months Sept, Oct, Nov for years 2011, 2012, 2013)
  • Frequency of insecticide resistance associated genotypes (kdr) in anopheles arabiensis(Yearly average 2011, 2012, 2013, 2014)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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