Applying Wolbachia to Eliminate Dengue (AWED): A Non-blinded Cluster Randomised Controlled Trial to Assess the Efficacy of Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Yogyakarta, Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8,173
- 试验地点
- 2
- 主要终点
- Relative risk of dengue in Wolbachia-treated versus untreated clusters
研究概览
简要总结
This cluster randomised trial will evaluate the efficacy of Wolbachia-infected Aedes aegytpi mosquitoes in reducing dengue cases in Yogyakarta City, Indonesia
详细描述
Primary objective:
To assess the efficacy of community-based deployments of Wolbachia-infected Aedes aegypti mosquitoes in reducing the incidence of symptomatic, virologically-confirmed dengue cases of any severity in Yogyakarta residents aged 3-45 years in release areas, relative to non-release areas.
Secondary objectives:
- To measure the efficacy of the Wolbachia method against each of the four DENV serotypes.
- To measure the efficacy of the Wolbachia method in reducing the incidence of symptomatic virologically confirmed Zika virus and chikungunya virus infection in release areas, relative to non-release areas
- To quantify the level of human mobility within Yogyakarta City, and estimate the proportion of residents' exposure time that they spend outside the treatment arm to which they were randomised
- To determine whether community-based deployment of Wolbachia-infected Ae. aegypti mosquitoes reduces the abundance of wild-type Ae. aegypti adults, or alternatively, alters the abundance of adults from Aedes species other than Ae. aegypti (e.g. Ae. albopictus)
Study setting:
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
- 3 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fever (either self-reported or objectively measured, e.g. (tympanic membrane temperature ≥38oC)) of 1-4 days duration, and where onset was prior to the day of presentation
- •Aged between 3-45 years old
- •Resided in the study area every night for the 10 days preceding illness onset
排除标准
- •Localising features suggestive of a specific diagnosis other than an arboviral infection e.g. severe diarrhea, otitis, pneumonia
- •Prior enrollment in the study within the previous 4 weeks
结局指标
主要结局
Relative risk of dengue in Wolbachia-treated versus untreated clusters
时间窗: Up to 36 months participant enrolment
Symptomatic, virologically-confirmed dengue virus (DENV) infection of any severity
次要结局
- Relative risk of serotype-specific dengue in Wolbachia-treated versus untreated clusters(Up to 36 months participant enrolment)
- Relative risk of Zika in Wolbachia-treated versus untreated clusters(Up to 36 months participant enrolment)
- Relative risk of Chikungunya in Wolbachia-treated versus untreated clusters(Up to 36 months participant enrolment)
研究者
Riris Andono Ahmad
Director of Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada
Gadjah Mada University