Urinary SchistosomiasesNCT05276414
Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag
An observational study of Urinary Schistosomiases, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Urinary Schistosomiases
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Samples will be collected from outpatient children aged between 5 - 16 years from Pediatric outpatient Clinics in Sohag hospitals.
Who may be able to join
- 100 outpatient children aged between 5 - 16 years
Who cannot join
- Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine,Sohag University
Sohag, 093
Asmaa k Abd Ellah, lecturer
Elsayed M Abdelkreem, lecturer
About this study
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
- Medical subject headings
- Schistosomiasis haematobia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks following the startpoint of the study.
Secondary outcomes (1)
to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag
By examining the stool samples of 100 outpatient children and recording the number of cases with Schistosoma haematobium infection.
Measured: 16 weeks following the startpoint of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start15 Mar 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary SchistosomiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Kamal Abdellah, Sohag University
- Investigators
- Asmaa K Abd Ellah, lecturer, Principal investigator, Medical Parasitology, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276414
- Sponsor's protocol ID
- Soh-Med-22-02-31
- Status last verified
- Apr 2022
- First submitted
- 2 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag
- ClinicalTrials.gov ID
- NCT05276414
- Acronym / sponsor ID
- Soh-Med-22-02-31
- Conditions
- Urinary Schistosomiases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Samples will be collected from outpatient children aged between 5 - 16 years from Pediatric outpatient Clinics in Sohag hospitals.
Key inclusion criteria (1 listed)
- 100 outpatient children aged between 5 - 16 years
Key exclusion criteria (1 listed)
- Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag
Time frame: 16 weeks following the startpoint of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
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Schistosoma Haematobium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa K Abd Ellah, lecturer principal investigator
Medical Parasitology, Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Schistosomiases, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa K Abd Ellah, lecturer (01067123632 ext. +20, Asmaakamal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.