Innovation Platform
- Conditions
- Malaria
- Registration Number
- NCT04558528
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Brief Summary
In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR\~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
- Aged 5 years or older
- Presenting at the study site with symptoms and signs suggestive of malaria
- Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
- Willing to provide sample at enrolment
- Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical performance assessment up to 6 months Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV, and DOR) of nPOC using nPCR as reference for detecting malaria in patients with symptoms suggestive of malaria
Concordance up to 6 months Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Stansile
🇷🇼Kigali, Rwanda
Eijkman Institute for Molecular Biology
🇮🇩Jakarta, Indonesia