CRUN

DIAGMAL

Title Description
Project Title

Phase 3 evaluation of an innovative simple molecular test for the diagnostic of malaria in different endemic and health settings in sub-Saharan Africa

(Acronyme : DIAGMAL)

   
Identity of the Site Study Coordinator François KIEMDE, MSc, PhD
   
Summary

This is a Phase 3 diagnostic evaluation, aimed to evaluate the performance of the mini-dbPCR-NALFIA test for malaria compared to the available diagnostic practice in place at the selecting settings (microscopy and/or RDT) and quantitative PCR as the reference test. Alongside this, we undertake to determine the cost effectiveness of implementing the new diagnostic test in health systems in the participating countries. Furthermore, we will compile a draft registration dossier for the diagnostic platform and explore a potential route to market.

Five African countries will participate in this clinical trial: Burkina Faso, Ethiopia, Kenya, Namibia and Sudan.

   
Field of application Diagnostic trials
   
Objectives

Primary objective:To assess the diagnostic accuracy of the mini-dbPCR-NALFIA test for the diagnosis of malaria compared to routine diagnostic procedure(s) in place (microscopy and/or RDTs) and qPCR in different clinical and field scenarios: a high malaria incidence region (Sudan), a seasonal malaria transmission setting where HRP2-RDTs result in false positive outcomes (Burkina Faso), an area with possible HRP2-deletions and high prevalence of vivax malaria (Ethiopia), a low transmission (near elimination) setting (Namibia) and Kenya, which has several different malaria zones: meso-hyperendemic (transmission all year round with seasonal peaks) in the lake and coastal areas; hypoendemic in the desert regions; and potential for outbreaks in the highlands (non-immunes).

 

Secondary objective:

1-To determine the direct and indirect costs and benefits of allocating limited resources to implement the mini-dbPCR-NALFIA test for malaria compared to current diagnostic strategies in place.

2-To determine potential barriers to successfully implementing the new diagnostic platform within local, socio-economic and cultural contexts under routine conditions.

3-To build a draft product dossier for CE marking and pre-qualification and to identify potential producers that can bring the platform to the market (exploitation objective).

4-To strengthen the capacity of all five African partners in the field of diagnostic clinical trials, including Good Clinical and Laboratory Practice (GC/LP) training of research and auxiliary staff and prospective MSc/ PhD students, and to improve the research infrastructure at the trial sites.

5-To disseminate the outcomes of the project to stakeholders, including scientific peers, diagnostic entities, policy makers and the lay public.

   
Start Date December 2019
   
Probable End Date November 2023
   
Website http://malariadx.org/project.html

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