Clinical trial NCT03834337: Treatment of Patients With Active Neurocysticercosis in Eastern Africa
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocysticercosis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
name: University of Zambia
name: Sokoine University of Agriculture
First posted: 2019-02-07
Enrollment: 63
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania and Zambia

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Resolution of lesions
timeFrame: Change in number of active cysts from before treatment to six months after treatment termination
measure: Symptom/sign frequency
timeFrame: Change of symptom/sign frequency from before treatment to six months after treatment termination
Secondary outcomes:
measure: Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire
timeFrame: Change in quality of life from before treatment to six months after treatment termination
measure: Health-related Quality of Life (epileptic patients)
timeFrame: Change in quality of life from before treatment to six months after treatment termination
measure: Change in presence of T.solium-specific antigen
timeFrame: Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: National Institute of Medical Research
Study officials:
References:
citation: 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.