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奥立克®Plus 天花板蚊帐减少肯尼亚维多利亚湖流域儿童疟疾流行率的效果评价:一项整群随机对照试验研究方案。

Evaluation of the protective efficacy of Olyset®Plus ceiling net on reducing malaria prevalence in children in Lake Victoria Basin, Kenya: study protocol for a cluster-randomized controlled trial.

机构信息

Department of Virology and Parasitology/Research Center for Infectious Diseases, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.

Directorate of Research and Innovation, Mount Kenya University, Thika, Kenya.

出版信息

Trials. 2023 May 25;24(1):354. doi: 10.1186/s13063-023-07372-3.

Abstract

BACKGROUND

In the Lake Victoria Basin of western Kenya, malaria remains highly endemic despite high coverage of interventions such as insecticide-impregnated long-lasting insecticidal nets (LLIN). The malaria-protective effect of LLINs is hampered by insecticide resistance in Anopheles vectors and its repurposing by the community. Ceiling nets and LLIN with synergist piperonyl butoxide (PBO-LLIN) are novel tools that can overcome the problems of behavioral variation of net use and metabolic resistance to insecticide, respectively. The two have been shown to reduce malaria prevalence when used independently. Integration of these two tools (i.e., ceiling nets made with PBO-LLIN or Olyset®Plus ceiling nets) appears promising in further reducing the malaria burden.

METHODS

A cluster-randomized controlled trial is designed to assess the effect of Olyset®Plus ceiling nets on reducing malaria prevalence in children on Mfangano Island in Homa Bay County, where malaria transmission is moderate. Olyset®Plus ceiling nets will be installed in 1315 residential structures. Malaria parasitological, entomological, and serological indicators will be measured for 12 months to compare the effectiveness of this new intervention against conventional LLIN in the control arm.

DISCUSSION

Wider adoption of Olyset®Plus ceiling nets to complement existing interventions may benefit other malaria-endemic counties and be incorporated as part of Kenya's national malaria elimination strategy.

TRIAL REGISTRATION

UMIN Clinical Trials Registry UMIN000045079. Registered on 4 August 2021.

摘要

背景

在肯尼亚西部的维多利亚湖流域,尽管干预措施(如驱虫处理的长效蚊帐(LLIN))的覆盖率很高,但疟疾仍然高度流行。杀虫剂抗性和社区重新利用杀虫剂,阻碍了 LLIN 的疟疾防护效果。天花板蚊帐和含有增效剂增效醚的 LLIN(PBO-LLIN)是两种新工具,分别可以克服蚊帐使用行为变化和杀虫剂代谢抗性的问题。这两种工具独立使用时都已被证明可以降低疟疾的患病率。这两种工具的整合(即用增效醚处理的 PBO-LLIN 制成的天花板蚊帐或 Olyset®Plus 天花板蚊帐)似乎有望进一步降低疟疾负担。

方法

设计了一项集群随机对照试验,以评估 Olyset®Plus 天花板蚊帐在降低霍马湾县 Mfangano 岛上儿童疟疾患病率方面的效果,该岛的疟疾传播处于中等水平。将在 1315 个住宅结构中安装 Olyset®Plus 天花板蚊帐。将在 12 个月内测量疟疾寄生虫学、昆虫学和血清学指标,以比较这种新干预措施与对照臂中常规 LLIN 的有效性。

讨论

更广泛地采用 Olyset®Plus 天花板蚊帐来补充现有干预措施可能会使其他疟疾流行县受益,并被纳入肯尼亚国家消除疟疾战略的一部分。

试验注册

UMIN 临床研究注册 UMIN000045079。注册于 2021 年 8 月 4 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ed6/10210418/2bbac0623a43/13063_2023_7372_Fig1_HTML.jpg

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