Innovation Platform

NCT04558528 | Completed

• 1 other identifier: MA014
• Study Type: observational
• Target: 640
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Novel in vitro diagnostics and medical applications DIAGNOSTIC_TEST

Novel in vitro diagnostics and medical applications

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (2)

Eijkman Institute for Molecular Biology

Jakarta, 10430, Indonesia

Location

Stansile

Kigali, KG622, Rwanda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ID (1); RW (1)