Innovation Platform

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558528
• Other study ID #: MA014
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
Indonesia	Eijkman Institute for Molecular Biology	Jakarta
Rwanda	Stansile	Kigali

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Countries where clinical trial is conducted

Indonesia,  Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance assessment	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	up to 6 months
Primary	Concordance	Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading	up to 6 months