NCT03874689

Brief Summary

This study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (Gwembe) and eastern province (Chipata) of Zambia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

3.6 years

First QC Date

March 12, 2019

Last Update Submit

November 27, 2023

Conditions

Keywords

Neurocysticercosis

Outcome Measures

Primary Outcomes (3)

  • Prevalence of T. solium cysticercosis

    Prevalence of human T. solium cysticercosis

    Assessment through blood sampling at baseline

  • Prevalence of neurocysticercosis

    Prevalence of human neurocysticercosis among people with positive serology for T. solium cysticercosis

    Assessment at CT scanning at baseline

  • Prevalence of taeniosis

    Prevalence of human T. solium taeniosis

    Assessment through stool sampling at baseline

Secondary Outcomes (1)

  • Prevalence of intestinal helminth infection

    Assessment through stool sampling at baseline

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study participants will be sampled from villages of two districts in Sambia (Gwembe and Chipata). Villages of these districts will be selected at random and all people from these villages will be invited to take part in the study. No selection apart from the exclusion criteria will take place.

You may qualify if:

  • Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets
  • Willing and able to provide informed consent (signature or thumbprint with impartial witness; assent for minors with parental consent).
  • Living in, attending school in, or regularly visiting the bore holes present in, the study communities.
  • Aged 10 years or older

You may not qualify if:

  • 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 group discussions, or taking oral anthelmintic tablets.
  • Unwilling or unable to provide written (signature or thumbprint with impartial witness) informed consent (or assent for minors).
  • Living outside of, and not regularly visiting, or attending school in, the study communities.
  • Children aged less than 10 years.
  • Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zambia

Lusaka, 32379, Zambia

Location

Related Publications (1)

  • Zulu G, Sikasunge CS, Welte TM, Simuunza MC, Stelzle D, Schmidt V, Hachangu A, Mutale W, Masuku M, Chembensofu M, da Costa CP, Mwape KE, Winkler AS, Phiri IK. Epidemiology of intestinal helminthiasis with an emphasis on taeniasis in Chipata district of the Eastern province of Zambia. PLoS Negl Trop Dis. 2023 Nov 20;17(11):e0011561. doi: 10.1371/journal.pntd.0011561. eCollection 2023 Nov.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool sample

MeSH Terms

Conditions

Neurocysticercosis

Condition Hierarchy (Ancestors)

Central Nervous System HelminthiasisCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesCysticercosisTaeniasisCestode InfectionsHelminthiasisCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chummy S. Sikasunge, PhD

    University of Zambia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations