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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
PACTR202009780096688 |
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Date of registration:
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14/09/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis
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Scientific title:
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A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis |
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Date of first enrolment:
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01/10/2020 |
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Target sample size:
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776 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12367 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Non-randomised,Numbered containers
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Phase:
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Not Applicable
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Sarah
Nogaro |
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Address:
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Campus Biotech
Geneva
Switzerland |
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Telephone:
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+41227100590 |
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Email:
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Sarah.Nogaro@finddx.org |
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Affiliation:
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Senior Scientific Officer |
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Name:
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Henry
Kanyi |
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Address:
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Mbagathi Road
Nairobi
Kenya |
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Telephone:
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+254788922040 |
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Email:
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kanyi2009@gmail.com |
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Affiliation:
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Research Scientist |
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Key inclusion & exclusion criteria
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Inclusion criteria: Individuals aged 5 years and above
Residents of study areas for a period of at least 1 year
Willingness to provide informed consent
Willingness to provide stool, urine and blood samples
Exclusion criteria: Individuals above 100 years of age or who feels/appears unwell
Unable to provide a blood and one-day stool and urine sample
Individual has taken praziquantel within the past 2 months
Age minimum:
6 Year(s)
Age maximum:
12 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schistosomiasis
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Schistosomiasis
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Intervention(s)
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Kato Katz and Urine Filtration microscopy
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Rapid diagnostic test
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Primary Outcome(s)
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Clinical sensitivity of the CAA prototype RDT in a schistosomiasis endemic area; Clinical specificity of the CAA prototype RDT in a schistosomiasis endemic area; Clinical specificity of the CAA prototype RDT in a schistosomiasis non-endemic area
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Secondary Outcome(s)
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Percentage agreement between finger prick and venous blood, and between finger prick and microscopy-based methods, and venous blood and microscopy-based methods; Stratification of the clinical sensitivity and specificity across three age groups (5-9, 10-15, >15 years old), across three levels of infection intensity (low, moderate and high), and for each sample type (venous blood and finger prick blood); Description of test operator experience with the CAA prototype RDT
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Source(s) of Monetary Support
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Foundation for Innovative New Diagnostics
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Ethics review
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Status: Approved
Approval date: 02/09/2020
Contact:
seru@kemri.org
seru@kemri.org
+254717719477
seru@kemri.org
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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