Innovation Platform

Foundation for Innovative New Diagnostics (FIND)

Status: Completed

Conditions: Malaria

Treatments: Diagnostic Test: Novel in vitro diagnostics and medical applications

Study type: Observational

Funder types: Other

Identifiers

NCT04558528

MA014

Details and patient eligibility

About

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.

Enrollment: 640 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines