Clinical evaluation of Malaria rapid antigen test
Phase 3
Not yet recruiting
- Conditions
- Malaria
- Registration Number
- PACTR202407803149023
- Lead Sponsor
- SD Biosensor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
Presenting at the study site with fever or a history of fever during the preceding 48-hours
Freely agreeing to participate by providing informed consent (and assent, as applicable
Exclusion Criteria
Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative diagnostic sensitivity and specificity shall be determined for each claimed specimen type.
- Secondary Outcome Measures
Name Time Method RDT positivity rate
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the detection of Plasmodium antigens by Malaria rapid diagnostic test kits in phase III trials?
How does the Malaria rapid antigen test compare to standard-of-care diagnostics like PCR and microscopy in clinical settings?
Which biomarkers are critical for optimizing patient selection in Malaria diagnostic trials using rapid antigen tests?
What adverse events are associated with Malaria rapid diagnostic test implementation in endemic regions?
What are the key differences between SD Biosensor's Malaria rapid test and competitor assays like BinaxNOW or CareStart?