OnchocerciasisOAEMaridiNCT05750043
Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan
An observational study of Onchocerciasis and Epilepsy, run by Universiteit Antwerpen at 1 site in South Sudan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Onchocerciasis, Epilepsy
- What is being tested?
- bi-annual CDTI
- How many people
- 17,000 participants
- Where
- 1 siteSouth Sudan
- Study dates
- 1 Mar 2018to 19 Feb 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- entire population of selected villages in Maridi County
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
South Sudan1 site
Amref Health Africa
Juba, Central, 140
About this study
Official title: Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan, a Three-year Prospective Study
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.
Read the detailed 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.
- Conditions
- Onchocerciasis, Epilepsy
- Being tested
- bi-annual CDTI
- Medical subject headings
- Onchocerciasis, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bi-annual CDTIDrug
Also called "slash and clear" vector control intervention
bi-annual community directed treatment with ivermectin (CDTI) and community-based "slash and clear" vector control intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: bi-annual CDTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
epilepsy incidence
Incidence of epilepsy including nodding syndrome
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Mar 2018
- Primary completion31 Jan 2023
- Study completion19 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnchocerciasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 17,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Amref Health Africa
- Responsible party
- Principal investigator, Robert Colebunders, Universiteit Antwerpen
- Investigators
- Jane Carter, MD, Principal investigator, Amref Health Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750043
- Sponsor's protocol ID
- Project Code AID 011898
- Acronym
- OAEMaridi
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan, a Three-year Prospective Study
- ClinicalTrials.gov ID
- NCT05750043
- Acronym / sponsor ID
- OAEMaridi / Project Code AID 011898
- Conditions
- Onchocerciasis, Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Amref Health Africa
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 19 Feb 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of selected villages in Maridi county | – | Drug: bi-annual CDTIA total of 2,511 households containing 17,652 individuals were visited in 2018, and 2,254 households containing 14,402 individuals in 2022. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- entire population of selected villages in Maridi County
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bi-annual CDTIAlso: "slash and clear" vector control interventionbi-annual community directed treatment with ivermectin (CDTI) and community-based "slash and clear" vector control intervention | Drug | Population of selected villages in Maridi county |
Primary outcome
epilepsy incidence
Time frame: 4 years
Incidence of epilepsy including nodding syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Carter, MD principal investigator
Amref Health Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Onchocerciasis and Epilepsy, run by Universiteit Antwerpen at 1 site in South Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epilepsy incidence (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.