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

• Conditions: Urinary Schistosomiases

• Registration Number: NCT05276414
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-03-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-08
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of medicine,Sohag University; 🇪🇬 Sohag, Egypt