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Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05276414
Collaborator
(none)
100
Enrollment
1
Location
7.5
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Schistosomiasis is a chronic infection endemic in 74 tropical and sub-tropical countries. Sub-Saharan Africa carries the highest burden (90%) of schistosomiasis which caused by both Schistosoma mansoni and Schistosoma haematobium. The prevalence of Schistosomiasis should be assessed to control of the infection. This is usually achieved through surveys based on the use of traditional parasitological methods as urine filtration for S. haematobium. However, these traditional methods are time consuming, require an experienced technician and multiple samples due to light-infection and irregular shedding. Therefore, the point-of-care Circulating Cathodic Antigen (POC-CCA) urine test has been developed for the diagnosis of S. haematobium infection which is simple, rapid, sensitive and specific assay.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag
    Actual Study Start Date :
    Mar 15, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Oct 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. to evaluate the accuracy of rapid immunochromatographic assay (POC-CCA) compared with traditional microscopic examination for diagnosis of Schistosoma haematobium infection [16 weeks following the startpoint of the study.]

      comparing the sensitivity and specificity of rapid immunochromatographic assay with traditional microscopic examination for diagnosis of Schistosoma haematobium infection

    Secondary Outcome Measures

    1. to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag [16 weeks following the startpoint of the study.]

      By examining the stool samples of 100 outpatient children and recording the number of cases with Schistosoma haematobium infection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 100 outpatient children aged between 5 - 16 years
    Exclusion Criteria:
    • Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine,Sohag University Sohag Egypt 093

    Sponsors and Collaborators

    • Sohag University

    Investigators

    • Principal Investigator: Asmaa K Abd Ellah, lecturer, Medical Parasitology, Faculty of Medicine, Sohag University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asmaa Kamal Abdellah, lecturer of medical parasitology, faculty of medicine, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05276414
    Other Study ID Numbers:
    • Soh-Med-22-02-31
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Apr 1, 2022
    Additional relevant MeSH terms:
    Schistosomiasis
    Schistosomiasis haematobia

    Study Results

    No Results Posted as of Apr 8, 2022