跳至主要内容
临床试验/NCT05750043
NCT05750043已完成不适用

Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan, a Three-year Prospective Study

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 17,000 人开始时间: 2018年3月1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
入组人数
17,000
试验地点
1
主要终点
epilepsy incidence

研究概览

简要总结

For the first time using a prospective design, a study confirms the results of previous retrospective studies, which found that strengthening onchocerciasis elimination efforts decreases the incidence of epilepsy, including nodding syndrome. Therefore, this study confirms the solid epidemiological link between onchocerciasis and epilepsy.

This study also shows that a community-based "Slash and Clear" vector control method can effectively decrease blackfly biting rates and potentially decrease onchocerciasis transmission.

Moreover, this study shows that epilepsy is a major cause of death in onchocerciasis endemic areas with high ongoing transmission.

详细描述

Background High onchocerciasis transmission predisposes communities in endemic areas to a high epilepsy burden. The 4·4% (95%CI:4·1-4·7%) epilepsy prevalence documented in 2018 in Maridi, South Sudan, motivated the strengthening of onchocerciasis elimination measures. We evaluated the effect of these interventions on the incidence of epilepsy, including nodding syndrome (NS).

Methods Annual community-directed treatment with ivermectin (CDTi) was implemented in 2019, temporarily interrupted in 2020 and reimplemented biannually in 2021. Additionally, a community-based "Slash and Clear" vector control method was initiated in 2019 at the Maridi dam. A two-stage house-to-house survey was conducted before (2018) and after (2022) implementing the interventions, consisting of initial screening by community workers to detect suspected cases of epilepsy, followed by confirmation of the diagnosis by a trained clinician.

Finding Overall, 17,652 and 14,402 individuals participated in the pre- and post-intervention surveys, respectively. The epilepsy incidence decreased from 313·0 (95% confidence intervals (CI):273·7-357·7) to 34·7 (95%CI:17·6-66·1) per 100,000 person-years. Similarly, the incidence of NS decreased from 120·4 (95%CI:96·7-149·6) to 10·4 (95%CI:2·7-33·2) per 100,000 person-years. Despite biannual CDTi, only 56·6% of the population took ivermectin in 2021. Mortality of persons with epilepsy accounted for 17·1% (95%CI:14·0-20·7%) of the overall number of deaths in the population.

Interpretation In onchocerciasis-endemic areas with high prevalence of epilepsy, strengthening onchocerciasis elimination interventions can decrease the incidence of epilepsy, including NS. Additional efforts are needed in Maridi, where epilepsy is a major cause of mortality, to increase CDTi coverage and sustain blackfly control.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • entire population of selected villages in Maridi County

排除标准

  • 未提供

研究组 & 干预措施

Population of selected villages in Maridi county

A total of 2,511 households containing 17,652 individuals were visited in 2018, and 2,254 households containing 14,402 individuals in 2022.

干预措施: bi-annual CDTI (Drug)

结局指标

主要结局

epilepsy incidence

时间窗: 4 years

Incidence of epilepsy including nodding syndrome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Colebunders

Professor

Universiteit Antwerpen

研究点 (1)

Loading locations...

相似试验