NCT05750043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

February 19, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • epilepsy incidence

    Incidence of epilepsy including nodding syndrome

    4 years

Study Arms (1)

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.

Drug: bi-annual CDTI

Interventions

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

Also known as: "slash and clear" vector control intervention
Population of selected villages in Maridi county

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was conducted in 44 villages from eight study areas in the central area of Maridi County: Hai-Gabat, Hai-Matara, Hai-Tarawa, Kazana-1, Kazana-2, Kwanga, Mudubai and Nagbaka.

You may qualify if:

  • entire population of selected villages in Maridi County

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amref Health Africa

Juba, Central, 140, South Sudan

Location

MeSH Terms

Conditions

OnchocerciasisEpilepsy

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jane Carter, MD

    Amref Health Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

March 1, 2018

Primary Completion

January 31, 2023

Study Completion

February 19, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

After de-identification (text, tables, figures, and appendices), all individual participant data that underlie the results reported in this article will be made available immediately and indefinitely via the Zenodo repository following publication for anyone who wishes to access the data for any purpose.

Locations