Innovation Platform
November 15, 2023 updated by: Foundation for Innovative New Diagnostics, Switzerland
Clinical Validation of Novel Malaria Diagnostic Tools for Point-of-Care Testing
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
640
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to 6 months
|
|
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
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 21, 2020
First Posted (Actual)
September 22, 2020
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MA014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.