Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009780096688 Date of Approval: 16/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis
Official scientific title A performance evaluation of a prototype rapid diagnostic test for the diagnosis of schistosomiasis
Brief summary describing the background and objectives of the trial Current methods for diagnosis of schistosomiasis (bilharzia) rely on detection of parasite eggs in stool or urine by microscopy. These methods are simple but have reduced sensitivity in low prevalence settings. To support national schistosomiasis programmes to reach elimination target as defined by the World Health Organization, new and better diagnostic tests need to be developed. The aim of this study is to evaluate the performance of a CAA prototype point-of-care (POC) rapid diagnostic test (RDT) using freshly collected samples from schistosome infected and non-infected individuals living in Kenya.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Schistosomiasis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2020
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date 28/02/2021
Anticipated target sample size (number of participants) 776
Actual target sample size (number of participants) 776
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rapid diagnostic test Not Applicable 20 min Schistosomiasis prototype point-of-care (POC) rapid diagnostic test (RDT) 350
Control Group Kato Katz and Urine Filtration microscopy Not applicable 30 minutes Kato Katz and Urine Filtration microscopy 350 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 5 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2020 KEMRI Scientific and Ethics Research Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road, P.O. Box 54840 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 one day
Secondary Outcome 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 One month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute Mbagathi Road, P.O. Box 54840 Nairobi 00200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Foundation for Innovative New Diagnostics Campus Biotech Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Foundation for Innovative New Diagnostics Campus Biotech Geneva Switzerland Charities/Societies/Foundation
Secondary Sponsor Kenya Medical Research Institute Mbagathi Road Nairobi Kenya Medical Research Institute
COLLABORATORS
Name Street address City Postal code Country
Foundation for Innovative New Diagnostics Campus Biotech Geneva Switzerland
Kenya Medical Research Institute Mbagathi Road Nairobi Kenya
Ministry of Health Division of Vector Borne and Neglected Tropical Diseases Upper Hill Road Nairobi Kenya
University of Nairobi College of Health Sciences Upper Hill Road Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sammy Njenga sammynjenga@gmail.com +254735173372 Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi Kenya Research Scientist
Role Name Email Phone Street address
Scientific Enquiries Sarah Nogaro Sarah.Nogaro@finddx.org +41227100590 Campus Biotech
City Postal code Country Position/Affiliation
Geneva Switzerland Senior Scientific Officer
Role Name Email Phone Street address
Public Enquiries Henry Kanyi kanyi2009@gmail.com +254788922040 Mbagathi Road
City Postal code Country Position/Affiliation
Nairobi Kenya Research Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be made available, after deidentification Study Protocol 2 years Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information