Investigation of Environmental Factors Associated With Tr... | NCT03874689

Studies
Investigation of Environmental Factors Associated With Transmission of T. Solium in Endemic Villages of Zambia

NCT03874689

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Nov 30, 2023Actual

Enrollment

2,921Actual

Phase

Not provided

Conditions

Neurocysticercosis
Taeniosis

Interventions

Not provided

Countries

Zambia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Mar 12, 2019

First Submission Date that Met QC Criteria

Mar 12, 2019

First Posted Date

Mar 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The true prevalence of Neurocyticercosis in Zambia is not well known. Only one study which was a pilot study done in Katete district of eastern province demonstrated the prevalence of NCC among people with epilepsy. There is need to provide an accurate estimate of the prevalence of NCC among people with cysticercosis in Zambia as well as understand the clinical manifestations of the disease in humans. Data on the full range of clinical characteristics of NCC is essential to accurately estimate the burden of the disease in the community.

The epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on TSCT and NCC in various population groups (adults, children, and those living with epilepsy) in two provinces of Zambia. This will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of TSCT/NCC in the country.

Further, environmental factors that could play a role in the transmission and maintenance of T. solium eggs will be studied. This will provide essential data in understanding the epidemiology of the parasite in endemic regions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,921Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Prevalence of intestinal helminth infection	Prevalence of intestinal helminth infection	Assessment through stool sampling at baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Name	Affiliation	Role
Chummy S. Sikasunge, PhD	University of Zambia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Zambia		Lusaka		32379	Zambia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37983246	Result	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.

ID	Term
D020809	Central Nervous System Helminthiasis
D020807	Central Nervous System Parasitic Infections
D002494	Central Nervous System Infections
D007239	Infections