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

April 7, 2022 updated by: Asmaa Kamal Abdellah, Sohag University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 093
        • Recruiting
        • faculty of medicine,sohag university
        • Principal Investigator:
          • Asmaa k Abd Ellah, lecturer
        • Sub-Investigator:
          • Elsayed M Abdelkreem, lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Samples will be collected from outpatient children aged between 5 - 16 years from Pediatric outpatient Clinics in Sohag hospitals.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate the accuracy of rapid immunochromatographic assay (POC-CCA) compared with traditional microscopic examination for diagnosis of Schistosoma haematobium infection
Time Frame: 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
16 weeks following the startpoint of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag
Time Frame: 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.
16 weeks following the startpoint of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-22-02-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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