Innovation Platform

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eijkman Institute for Molecular Biology, Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel in vitro diagnostics and medical applications

Diagnostic Test

Novel in vitro diagnostics and medical applications

Primary outcomes

Clinical performance assessment

Time frame: 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

Time frame: up to 6 months

Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 22, 2020
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed