Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniosis and (euro)cysticercosis in Tanzania and Zambia

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201712002788898
• Date of registration: 21/11/2017
• Prospective Registration: Yes
• Primary sponsor: Institute of Tropical Medicine
• Public title: Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniosis and (euro)cysticercosis in Tanzania and Zambia
• Scientific title: Evaluation of an antibody detecting point-of-care test for the diagnosis of Taenia solium taeniasis and (neuro)cysticercosis in communities and district hospitals of highly endemic, resource-poor areas in sub Saharan Africa, including capacity building
• Date of first enrolment: 02/12/2017
• Target sample size: 3800
• Recruitment status: Other
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2788
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Diagnostic study with randomised and non-randomised part, randomisation based on household codes, tallying and coin-tossing,NA, diagnostic study
• Phase: Not Applicable

Countries of recruitment

Tanzania, Zambia

Contacts

• Name: Sarah GABRIEL
• Affiliation: Ghent University

• Name: Sarah GABRIEL
• Affiliation: Ghent University

Key inclusion & exclusion criteria

Inclusion criteria: Tanzania NCC:
Patients 10 years of age and above with on-going symptoms of severe progressive headache impeding the daily activities without fever and without signs of cerebral infection or other obvious causes OR patients 10 years of age and above with a history of one or more epileptic seizures without obvious causes
¿ Patients willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey, and undergoing brain
CT Scan if indicated
¿ Patients willing and able to provide written informed consent
¿ Patients living in the study area for the past three months and planning to stay in the same area throughout the study period
Tanzania T:
Patient must be 10 years and above and present at the out-patient clinic with
(1) intestinal complaints compatible with intestinal worm infection (diarrhoea > 2 weeks and/or abdominal pain/discomfort > 2 weeks and/or recent history of worm expulsion): SELECTIVE GROUP
(2) any other symptom not immediately linked with intestinal worm infection: RANDOM GROUP
¿ Patients willing and able to provide written informed consent
¿ Patients living in the study area for the past three months and planning to stay in the same area throughout the study period
Zambia (N)CC and T:
Patients willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey, and undergoing brain CT scan if indicated
¿ Willing and able to provide written informed consent
Living, attending school, or regularly visiting the bore holes present in the study
communities
¿ Aged 10 years of age or older
PhD study:
Individuals involved in the preparation of pork and that usually also eat pork
¿ Individuals older than 18 years of age
¿ Individuals willing and able to provide written informed consent

Exclusion criteria: Tanzania NCC:
¿ Patients less than 10 years of age
¿ Patients with any acute febrile illness
¿ Patients with fever and signs and symptoms for middle ear infection
¿ Patients with signs and symptoms of meningitis
¿ Patients with neck muscle pain and stiffness
¿ Patients with a history of stroke with neurological focal deficit
¿ Patients not willing or able to provide written informed consent (assent for minors)
¿ Patients not resident in the study area
¿ Patients reported pregnant
Tanzania T:
Patients below the age of 10 years
¿ Patients with acute severe illness that need in-patient care
¿ Patients not willing or able to provide written informed consent (assent for minors)
¿ Patient not resident in the study area
Zambia:
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
undergoing brain CT scan if indicated (clinically or per protocol)
¿ Unwilling or unable to provide written informed consent (assent for minors with
consent from a parent or a legally authorised representative)
¿ Living outside of, and not regularly visiting, or attending school in, the study
communities
¿ Children below the age of 10 years
¿ Children below the age of 10 years with severe malnutrition
¿ Reported pregnant
Seriously ill (unable to engage in the normal activities of daily living without
assistance because of the illnesses)
PhD:
Individuals below the age of 18 years
¿ Individuals not willing or able to provide written informed consent
¿ Individuals that previously participated in T. solium research projects

Age minimum: 10 Year(s)
Age maximum: 140 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

neurocysticercosis, taeniosis
neurocysticercosis, taeniosis

neurocysticercosis, taeniosis

Intervention(s)

Diagnostic study Zambia

Diagnostic study Tanzania

Primary Outcome(s)

POC test sensitivity and specificity for the detection of taeniosis and (neuro) csyticercosis at community level (Zambia) and at district hospital level (Tanzania)

Secondary Outcome(s)

Tanzania: Behavioural change following health education

Source(s) of Monetary Support

Bundesministerium fur Bildung und Forschung BMBF

EDCTP

Ethics review

Status: Approved
Approval date: 13/09/2017
Contact:

[e-mail]

University of Zambia Biomedical Research Ethics Committee

[phone]

[e-mail]

Status: Approved
Approval date: 18/09/2017
Contact:

[e-mail]

Universiteit Antwerpen Ethisch Comite

[phone]

[e-mail]

Status: Approved
Approval date: 10/10/2017
Contact:

[e-mail]

National Health Research Ethics CommitteeNational Institute for Medical Research

[phone]

[e-mail]