Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia

Neurocysticercosis Clinical Trial

— TEPIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874689
• Other study ID #: TEPIM
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2921
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis
• Taeniosis

Locations

Country	Name	City	State
Zambia	University of Zambia	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
Technical University of Munich

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

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 th — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of T. solium cysticercosis	Prevalence of human T. solium cysticercosis	Assessment through blood sampling at baseline
Primary	Prevalence of neurocysticercosis	Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis	Assessment at CT scanning at baseline
Primary	Prevalence of taeniosis	Prevalence of human T. solium taeniosis	Assessment through stool sampling at baseline
Secondary	Prevalence of intestinal helminth infection	Prevalence of intestinal helminth infection	Assessment through stool sampling at baseline

External Links

•   Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia