Treatment of Patients With Active Neurocysticercosis in Eastern Africa

NCT03834337 | Completed

• 1 other identifier: TOPANA
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurocysticercosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire

  Change in quality of life from before treatment to six months after treatment termination

• Health-related Quality of Life (epileptic patients)

  Change in quality of life from before treatment to six months after treatment termination

• Change in presence of T.solium-specific antigen

  Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Potential participants who are currently taking or have taken albendazole, praziquantel, or a corticosteroid within the past 12 months will be excluded.
• 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.

Sponsors & Collaborators

• Technical University of Munich: lead
• National Institute for Medical Research, Tanzania: collaborator
• University of Zambia: collaborator
• Sokoine University of Agriculture: collaborator

Study Sites (1)

National Institute of Medical Research

Dar es Salaam, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 36961623 RESULT

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and stool samples

MeSH Terms

Conditions

Neurocysticercosis

Condition Hierarchy (Ancestors)

Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Cysticercosis; Taeniasis; Cestode Infections; Helminthiasis; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 7, 2019
• Study Start: April 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

TA (1)