更新于：评估雄性沃尔巴克氏体感染蚊子的部署在降低新加坡登革热发病率方面的效果。
Update to: Assessing the efficacy of male Wolbachia-infected mosquito deployments to reduce dengue incidence in Singapore.
机构信息
Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.
Environmental Health Institute, National Environment Agency, Singapore, Singapore.
出版信息
Trials. 2024 Jun 20;25(1):400. doi: 10.1186/s13063-024-08148-z.
BACKGROUND
This trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Singapore, with the aim of measuring the efficacy of male Wolbachia-infected Aedes aegypti deployments in reducing dengue incidence in an endemic setting with all four dengue serotypes in circulation. The trial commenced in July 2022 and is expected to conclude in September 2024. The original study protocol was published in December 2022. Here, we describe amendments that have been made to the study protocol since commencement of the trial.
METHODS
The key protocol amendments are (1) addition of an explicit definition of Wolbachia exposure for residents residing in intervention sites based on the duration of Wolbachia exposure at point of testing, (2) incorporation of a high-dimensional set of anthropogenic and environmental characteristics in the analysis plan to adjust for baseline risk factors of dengue transmission, and (3) addition of alternative statistical analyses for endpoints to control for post hoc imbalance in cluster-based environmental and anthropogenic characteristics.
DISCUSSION
The findings from this study will provide the first experimental evidence for the efficacy of releasing male-Wolbachia infected mosquitoes to reduce dengue incidence in a cluster-randomised controlled trial. The trial will conclude in 2024 and results will be reported shortly thereafter.
TRIAL REGISTRATION
ClinicalTrials.gov, identifier: NCT05505682. Registered on 16 August 2022. Retrospectively registered. Last updated 11 November 2023.
背景
这是一项正在新加坡进行的平行、双臂、非盲、集群随机对照试验，旨在测量在流行环境中部署雄性感染沃尔巴克氏体的埃及伊蚊对减少登革热发病率的效果，该环境中有四种登革热血清型循环。该试验于 2022 年 7 月开始，预计于 2024 年 9 月结束。原始研究方案于 2022 年 12 月发表。在这里，我们描述了自试验开始以来对研究方案所做的修订。
方法
主要方案修订包括：（1）根据检测时沃尔巴克氏体暴露的持续时间，为居住在干预地点的居民添加了沃尔巴克氏体暴露的明确定义；（2）在分析计划中纳入了一组高维的人为和环境特征，以调整登革热传播的基线风险因素；（3）增加了替代终点的统计分析，以控制基于集群的环境和人为特征的事后不平衡。
讨论
这项研究的结果将提供释放雄性感染沃尔巴克氏体的蚊子以减少登革热发病率的首次实验证据，在集群随机对照试验中。该试验将于 2024 年结束，随后将很快报告结果。
试验注册
ClinicalTrials.gov，标识符：NCT05505682。于 2022 年 8 月 16 日注册。回顾性注册。最新更新日期为 2023 年 11 月 11 日。
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