Treatment of Patients With Active Neurocysticercosis in Eastern Africa

NCT ID: NCT03834337

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neurocysticercosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

University of Zambia

OTHER

Sponsor Role collaborator

Sokoine University of Agriculture

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Institute of Medical Research

Dar es Salaam, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type RESULT
PMID: 36961623 (View on PubMed)

Related Links

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http://link.springer.com/article/10.1007/s15010-023-02021-y

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

Other Identifiers

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TOPANA

Identifier Type: -

Identifier Source: org_study_id