Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan

Epilepsy Clinical Trial

— OAEMaridi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750043
• Other study ID #: Project Code AID 011898
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 19, 2023

Study information

• Verified date: November 2023
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17000
• Est. completion date: February 19, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• entire population of selected villages in Maridi County

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Epilepsy
• Onchocerciasis

Intervention

Drug:
• bi-annual CDTI
bi-annual community directed treatment with ivermectin (CDTI) and community-based "slash and clear" vector control intervention

Locations

Country	Name	City	State
South Sudan	Amref Health Africa	Juba	Central

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Amref Health Africa

Country where clinical trial is conducted

South Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epilepsy incidence	Incidence of epilepsy including nodding syndrome	4 years