Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05749653
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-02-17
Brief Title:
Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area
Sponsor:
Universiteit Antwerpen
Organization:
Universiteit Antwerpen
Study Overview
Official Title:
Impact of a Bi-annual Community-directed Treatment With Ivermectin Programme on the Incidence of Epilepsy in an Onchocerciasis-endemic Area of Mahenge Tanzania a Population-based Prospective Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OAETanzania
Brief Summary:
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:
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 201718 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 confirmreject 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
Methodology Door-to-door epilepsy surveys were conducted prior to 201718 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 confirmreject 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None