NeurocysticercosisTEPIMNCT03874689
Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia
An observational study of Neurocysticercosis and Taeniosis, run by Technical University of Munich at 1 site in Zambia.
Trial summary
This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocysticercosis, Taeniosis
- How many people
- 2,921 participants
- Where
- 1 siteZambia
- Study dates
- 1 Jun 2019to 31 Dec 2022
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study participants will be sampled from villages of two districts in Sambia (Gwembe and Chipata). Villages of these districts will be selected at random and all people from these villages will be invited to take part in the study. No selection apart from the exclusion criteria will take place.
Who may be able to join
- Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets
- Willing and able to provide informed consent (signature or thumbprint with impartial witness; assent for minors with parental consent).
- Living in, attending school in, or regularly visiting the bore holes present in, the study communities.
- Aged 10 years or older
Who cannot join
- Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets.
- Unwilling or unable to provide written (signature or thumbprint with impartial witness) informed consent (or assent for minors).
- Living outside of, and not regularly visiting, or attending school in, the study communities.
- Children aged less than 10 years.
- Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishment and Application of a Taenia Solium Experimental Pig Infection Model and Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Eastern and Southern Provinces of Zambia
This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia.
Read the detailed description
The true prevalence of Neurocyticercosis in Zambia is not well known. Only one study which was a pilot study done in Katete district of eastern province demonstrated the prevalence of NCC among people with epilepsy. There is need to provide an accurate estimate of the prevalence of NCC among people with cysticercosis in Zambia as well as understand the clinical manifestations of the disease in humans. Data on the full range of clinical characteristics of NCC is essential to accurately estimate the burden of the disease in the community.
The epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on TSCT and NCC in various population groups (adults, children, and those living with epilepsy) in two provinces of Zambia. This will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of TSCT/NCC in the country.
Further, environmental factors that could play a role in the transmission and maintenance of T. solium eggs will be studied. This will provide essential data in understanding the epidemiology of the parasite in endemic regions.
- Conditions
- Neurocysticercosis, Taeniosis
- Keywords
- Neurocysticercosis
- Medical subject headings
- Neurocysticercosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of T. solium cysticercosis
Prevalence of human T. solium cysticercosis
Measured: Assessment through blood sampling at baseline
Prevalence of neurocysticercosis
Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis
Measured: Assessment at CT scanning at baseline
Prevalence of taeniosis
Prevalence of human T. solium taeniosis
Measured: Assessment through stool sampling at baseline
Secondary outcomes (1)
Prevalence of intestinal helminth infection
Prevalence of intestinal helminth infection
Measured: Assessment through stool sampling at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chummy S. Sikasunge, PhD, Principal investigator, University of Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874689
- Sponsor's protocol ID
- TEPIM
- Acronym
- TEPIM
- Status last verified
- Nov 2023
- First submitted
- 12 Mar 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zulu G, Sikasunge CS, Welte TM, Simuunza MC, Stelzle D, Schmidt V, Hachangu A, Mutale W, Masuku M, Chembensofu M, da Costa CP, Mwape KE, Winkler AS, Phiri IK. Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia. PLoS Negl Trop Dis. 2023 Nov 20;17(11):e0011561. doi: 10.1371/journal.pntd.0011561. eCollection 2023 Nov.
PubMed 37983246
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
- Establishment and Application of a Taenia Solium Experimental Pig Infection Model and Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Eastern and Southern Provinces of Zambia
- ClinicalTrials.gov ID
- NCT03874689
- Acronym / sponsor ID
- TEPIM / TEPIM
- Conditions
- Neurocysticercosis, Taeniosis
- Keywords
- Neurocysticercosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,921 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Mar 2019 (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.
This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia.
Detailed description
The true prevalence of Neurocyticercosis in Zambia is not well known. Only one study which was a pilot study done in Katete district of eastern province demonstrated the prevalence of NCC among people with epilepsy. There is need to provide an accurate estimate of the prevalence of NCC among people with cysticercosis in Zambia as well as understand the clinical manifestations of the disease in humans. Data on the full range of clinical characteristics of NCC is essential to accurately estimate the burden of the disease in the community.
The epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on TSCT and NCC in various population groups (adults, children, and those living with epilepsy) in two provinces of Zambia. This will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of TSCT/NCC in the country.
Further, environmental factors that could play a role in the transmission and maintenance of T. solium eggs will be studied. This will provide essential data in understanding the epidemiology of the parasite in endemic regions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be sampled from villages of two districts in Sambia (Gwembe and Chipata). Villages of these districts will be selected at random and all people from these villages will be invited to take part in the study. No selection apart from the exclusion criteria will take place.
Key inclusion criteria (4 listed)
- Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets
- Willing and able to provide informed consent (signature or thumbprint with impartial witness; assent for minors with parental consent).
- Living in, attending school in, or regularly visiting the bore holes present in, the study communities.
- Aged 10 years or older
Key exclusion criteria (5 listed)
- Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets.
- Unwilling or unable to provide written (signature or thumbprint with impartial witness) informed consent (or assent for minors).
- Living outside of, and not regularly visiting, or attending school in, the study communities.
- Children aged less than 10 years.
- Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of T. solium cysticercosis
Time frame: Assessment through blood sampling at baseline
Prevalence of human T. solium cysticercosis
Prevalence of neurocysticercosis
Time frame: Assessment at CT scanning at baseline
Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis
Prevalence of taeniosis
Time frame: Assessment through stool sampling at baseline
Prevalence of human T. solium taeniosis
1 secondary outcome
Prevalence of intestinal helminth infection
Time frame: Assessment through stool sampling at baseline
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.
- Results publication: PubMed 37983246Zulu G, Sikasunge CS, Welte TM, Simuunza MC, Stelzle D, Schmidt V, Hachangu A, Mutale W, Masuku M, Chembensofu M, da Costa CP, Mwape KE, Winkler AS, Phiri IK. Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia. PLoS Negl Trop Dis. 2023 Nov 20;17(11):e0011561. doi: 10.1371/journal.pntd.0011561. eCollection 2023 Nov.
- Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of ZambiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Chummy S. Sikasunge, PhD principal investigator
University of Zambia
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 Neurocysticercosis and Taeniosis, run by Technical University of Munich at 1 site in Zambia.
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 4 inclusion and 5 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 Zambia. 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?
Prevalence of T. solium cysticercosis (time frame: Assessment through blood sampling at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874689, which also lists 1 linked publication.
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.