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Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area

NCT ID: NCT05749653

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-02-01

Brief Summary

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Onchocerciasis is a neglected tropical disease associated with epilepsy, particularly in areas of high Onchocerciasis volvulus transmission. Onchocerciasis-associated epilepsy is characterised by seizures that start between the ages of five to 18 years. The tropical disease can be controlled through community-directed treatment with ivermectin (CDTi). Mahenge, in Tanzania, had a high prevalence of onchocerciasis and epilepsy despite more than 20 years of annual CDTi. Hence, the Tanzanian Neglected Tropical Diseases Control Programme has switched from annual to bi-annually CDTi since 2019. After this switch, the CDTi coverage increased and was sustained in both ivermectin rounds in 2021, and the number of new epilepsy cases decreased. The latter were persons who did not take ivermectin the year they had the first seizures. Hence, all ivermectin-eligible children at risk of onchocerciasis should take ivermectin at least annually. Overall, increasing the frequency and coverage of the CDTi programme should be considered in onchocerciasis-endemic areas with a high prevalence of epilepsy.

Detailed Description

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Background: Community-directed treatment with ivermectin (CDTi) is used to eliminate onchocerciasis. However, despite 25 years of annual CDTi in Mahenge, Tanzania, the prevalence of onchocerciasis and onchocerciasis-associated epilepsy remained high in certain rural villages. Therefore, in 2019, bi-annual CDTi was introduced in the area. This study assessed the impact of the programme on the incidence of epilepsy in four villages.

Methodology: Door-to-door epilepsy surveys were conducted prior to (2017/18) and after (2021) implementing bi-annual CDTi. All household members were screened for epilepsy symptoms using a validated questionnaire, and suspected cases were examined by a medical doctor to confirm/reject the diagnosis of epilepsy. The prevalence and annual incidence of epilepsy, including nodding syndrome, were calculated with 95% Wilson confidence intervals with continuity correction. The latter was also done for CDTi coverage in 2021.

Conditions

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Onchocerciasis Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

population based study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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bi-annual CDTI

bi-annual CDTI with high coverage

Group Type OTHER

Bi-annual CDTI

Intervention Type DRUG

Bi-annual CDTI

Interventions

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Bi-annual CDTI

Bi-annual CDTI

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiteit Antwerpen

OTHER

Sponsor Role lead

Responsible Party

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Robert Colebunders

Emeritus professor, head NSETHIO research group, Global Health institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Mmbando, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Medical Research, Tanga

Locations

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National Institute of Medical Research

Tanga, , Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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B300201837863

Identifier Type: -

Identifier Source: org_study_id