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

NCT05276414 | Unknown

• 1 other identifier: Soh-Med-22-02-31
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Schistosomiases

Outcome Measures

Primary Outcomes (1)

• to evaluate the accuracy of rapid immunochromatographic assay (POC-CCA) compared with traditional microscopic examination for diagnosis of Schistosoma haematobium infection

  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 Outcomes (1)

• to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag

  16 weeks following the startpoint of the study.

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• outpatient children aged between 5 - 16 years

You may not qualify if:

• Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine,Sohag University

Sohag, 093, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine samples

MeSH Terms

Conditions

Schistosomiasis haematobia

Condition Hierarchy (Ancestors)

Schistosomiasis; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Urinary Tract Infections; Vector Borne Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Asmaa K Abd Ellah, lecturer

  Medical Parasitology, Faculty of Medicine, Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa K Abd Ellah, lecturer

CONTACT

01067123632; Asmaakamal@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of medical parasitology, faculty of medicine

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: March 15, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Locations

EG (1)