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临床试验/NCT05505682
NCT05505682已完成不适用

Assessing the Efficacy of Male Wolbachia-infected Mosquito Deployments to Reduce Dengue Incidence in Singapore: a Cluster Randomized Controlled Trial

National Environment Agency, Singapore1 个研究点 分布在 1 个国家目标入组 724,428 人开始时间: 2022年7月28日最近更新:
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
发起方
入组人数
724,428
试验地点
1
主要终点
Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters

研究概览

简要总结

The study is a cluster-randomised controlled trial set in Singapore, to assess if the deployment of male Wolbachia-infected Aedes aegypti mosquitoes can reduce dengue incidence in intervention clusters.

详细描述

The study is designed as a parallel, two-arm, non-blinded cluster-randomised controlled trial to be conducted in high-rise public housing estates in Singapore. The aim is to determine whether large-scale deployment of male Wolbachia-infected Ae. aegypti mosquitoes can significantly reduce dengue incidence in intervention clusters. The investigators will use the cluster-randomised design, with the study area comprising 15 clusters with a total area of 10.9 km2, covering approximately 722,000 residents in 1,700 apartment blocks. Eight clusters will be randomly selected to receive the intervention, while the other seven will serve as non-intervention clusters. Intervention efficacy will be estimated through two primary endpoints: (1) odds ratio of Wolbachia exposure distribution (i.e. probability of living in an intervention cluster) among laboratory-confirmed reported dengue cases compared to test-negative controls, and (2) laboratory-confirmed reported dengue counts normalized by population size in intervention versus non-intervention 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

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention clusters

Experimental

Residential areas that receive releases of male Wolbachia-infected Aedes aegypti

干预措施: Biological (Male Wolbachia-infected Aedes aegypti) (Biological)

结局指标

主要结局

Laboratory-confirmed reported dengue case counts normalized by population size in intervention versus non-intervention clusters

时间窗: Up to 3 years

Dengue cases data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

Odds ratio of Wolbachia exposure distribution among laboratory-confirmed reported dengue cases compared to test-negative controls

时间窗: Up to 3 years

Dengue cases and dengue test-negative controls data will be obtained from the national surveillance network of diagnostic laboratories which receive samples for dengue testing.

次要结局

  • Prevalence of Ae. aegypti/Ae. albopictus mosquitoes(Up to 3 years)
  • Public Attitudes, Perceptions & Knowledge (APK) of Wolbachia and other vector control interventions(Up to 3 years)

研究者

发起方
National Environment Agency, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lee Ching Ng

Group Director (Environmental Health Institute)

National Environment Agency, Singapore

研究点 (1)

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