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临床试验/NCT02458066
NCT02458066已完成不适用

Cluster Randomised Trial to Compare Effectiveness of Bendiocarb and Deltamethrin (Long-Lasting) in Preventing Malaria Infection

Medical Care Development, Inc.0 个研究点目标入组 2,800 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,800
主要终点
Prevalence of falciparum infection in 2-14 year olds

研究概览

简要总结

Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island to be sprayed with either a long lasting pyrethroid insecticide, K-Othrine SC 62.5, or a bendiocarb insecticide, FICAM. Parasite prevalence in children aged 2-14 was measured before and after the application of insecticide.

详细描述

In 2013, a new long lasting pyrethroid insecticide, K-Othrine SC 62.5, that has been developed by Bayer AG, was used for the IRS program in Bioko Island, Equatorial Guinea, for the first time. This change coincided with a marked increase in parasite prevalence in 2-14 year olds as measured in the Annual Malaria Indicator Survey (14% to 28%, respectively). In order to determine whether the change in insecticide caused the increase in prevalence, a cluster randomized control trial was designed.

Twenty-four (24) clusters, each containing between 250-300 houses were selected throughout Bioko Island. Clusters were chosen with an attempt to maximize the geographical space between clusters (to minimize possible residual effects from insecticides), while ensuring that areas with historically higher acceptance rates for Indoor Residual Spraying (IRS) were selected. Each cluster had a buffer zone of 300m (or halfway between clusters less than 600m apart).

A team of 10 local surveyors conducted a baseline survey in each cluster area, measuring prevalence through malaria Rapid Diagnostic Test (RDT) positivity, net ownership, spray coverage, and hemoglobin levels. Approximately 100 children in each cluster were tested. These data were then used for a restricted randomization. Each cluster was then sprayed with either deltamethrin or bendiocarb, depending on randomization. The IRS team put equal amount of effort into each cluster, as determined by number of sprayers/house/day in an attempt to minimize bias.

An end-line survey was conducted using an ODK Collect application in the same cluster areas. Prevalence was measured by RDT, and hemoglobin data was gathered. In addition, the head of household was asked about the acceptability to IRS and their willingness to receive the insecticide in a future round.

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
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 2-14 years old who reside in a household within the intervention area
  • Household clusters chosen among those with historically high IRS acceptance rate
  • Household clusters chosen to maximize distance between clusters.

排除标准

  • Areas with historically high rates of refusing IRS

结局指标

主要结局

Prevalence of falciparum infection in 2-14 year olds

时间窗: 3-5 months post receiving IRS

Cross sectional Rapid Diagnostic Test (RDT)-based prevalence of infection of P.falciparum in children between the ages of 2 and 14 of the participating localities.

次要结局

  • Prevalence of infection, adjusted for potential cofounders in 2-14 year olds(3-5 months post receiving IRS)
  • Severe anemia in children under 5(3-5 months post receiving IRS)

研究者

发起方
Medical Care Development, Inc.
申办方类型
Other
责任方
Sponsor

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