Treatment of Patients With Active Neurocysticercosis in Eastern Africa (TOPANA)

Characteristics of Patients With Symptomatic Active Neurocysticercosis and Effect of Treatment on Symptoms, Lesions and Quality of Life in Resource-poor Rural Areas of Eastern Africa - TOPANA, a Multi-centre Prospective Cohort Study.

This multi-centre prospective cohort study of symptomatic patients with active neurocysticercosis (NCC) aims to identify factors related to treatment success of anthelmintic therapy.

Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of serological T. solium diagnostics and NCC-specific immunological parameter will be followed up at multiple time points in the study. The final assessment will be done six months after the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan Africa by identifying factors that are associated with treatment outcomes.

The factors that cause some people to fail complete resolution of all cysts and/or symptoms/signs are unknown.

Study Overview

• Status: Completed
• Conditions: Neurocysticercosis

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • National Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania and Zambia

Description

Inclusion Criteria:

• All patients will be included who
• Meet the definitions of active NCC
• Have epilepsy, epileptic seizures or chronic/severe progressive headaches
• Are physically and mentally fit enough for treatment
• Are willing to be hospitalized and to receive the standard treatment for NCC
• Are willing to participate a follow-up for six months
• Are willing and able to consent to this study, with consent recorded on a signed consent form

Exclusion Criteria:

• Potential participants who will not meet the above inclusion criteria will be excluded.
• Women who are pregnant will not be included, but re-evaluated for inclusion into the study after they have given birth.
• Potential participants who are currently taking or have taken albendazole, praziquantel, or a corticosteroid within the past 12 months will be excluded.
• People with uncontrolled hypertension and/or diabetes will be excluded from the study but will be re-evaluated for inclusion once their hypertension and/or diabetes have been treated.
• People with chronic consuming illness such as cancer and those with mental handicap severe enough to not allow them to follow the study instructions or reliably take their medication will be excluded.
• Children aged <10 years.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom/sign frequency	The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.	Change of symptom/sign frequency from before treatment to six months after treatment termination
Resolution of lesions	The number of active cysts identified by CT scan after treatment	Change in number of active cysts from before treatment to six months after treatment termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in presence of T.solium-specific antigen	Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis	Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination
Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire	The change in participants' self-reported quality of life from before to after treatment, as measured by the WHOQOL-Bref questionnaire (in all participants) [World Health Organization Quality of Life questionnaire; consisting of 26 items]. Quality of life is assessed by four domains - physical health, psychological, social relationships and environment. In each domain a score of 0 to 100 can be achieved. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Domains are not summarised to an overall score.	Change in quality of life from before treatment to six months after treatment termination
Health-related Quality of Life (epileptic patients)	The change in participants' self-reported quality of life from before to after treatment, as measured by the QOLIE-31 questionnaire [Quality of life in epilepsy - 31 items]. The score consists of 7 domains which all are range from 0 to 100%. Those domains are: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive, medication effects, social function. The seven domains are then summarized to an overall score by applying weights to each category. The overall score ranges from 0 to 100% with 100% being best possible quality of life.	Change in quality of life from before treatment to six months after treatment termination

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: National Institute for Medical Research, Tanzania; University of Zambia; Sokoine University of Agriculture

Publications and helpful links

General Publications

• Stelzle D, Makasi C, Schmidt V, Trevisan C, Van Damme I, Ruether C, Dorny P, Magnussen P, Zulu G, Mwape KE, Bottieau E, Prazeres da Costa C, Prodjinotho UF, Carabin H, Jackson E, Fleury A, Gabriel S, Ngowi BJ, Winkler AS. Efficacy and safety of antiparasitic therapy for neurocysticercosis in rural Tanzania: a prospective cohort study. Infection. 2023 Aug;51(4):1127-1139. doi: 10.1007/s15010-023-02021-y. Epub 2023 Mar 24.

Helpful Links

• Efficacy and safety of antiparasitic therapy for neurocysticercosis in rural Tanzania: a prospective cohort study

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Parasitic Diseases; Helminthiasis; Cestode Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Cysticercosis; Taeniasis; Neurocysticercosis
• Other Study ID Numbers: TOPANA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No