CRUN

e-MANIC

 

Title

Development and evaluation of an electronic diagnostic algorithm using a combination of a two-step malaria rapid diagnostic test detecting PfHRP2 and pLDH, biomarkers and bacterial pathogen specifics point of care tests for the management of febrile illnesses in children under 5 years attending outpatient facilities in Burkina Faso. (Acronym : e-MANIC)

   

Identity of the Site Study Coordinator 

François KIEMDE, MSc, PhD

   

·Summary

This is a diagnostic study aimed to improve the diagnostic and treatment of febrile diseases in children under 5 years attending the outpatient facilities. During the project, a panel of researchers working on pediatric care such as pediatricians (professional and academic), clinicians, nurses, biologists and computer program developer will develop and evaluate a diagnostic tool (algorithm) to guide the diagnostic and treatment of febrile diseases in children under 5 years. This algorithm will the combination of two-step malaria rapid diagnostic test detecting PfHRP2/pLDH, biomarkers and bacterial pathogen specifics point-of-care tests to improve the diagnostic and the treatment of malaria and bacterial infections and tackle inappropriate use of antibiotic.

The study also has social science component that aims to assess the adherence of healthcare workers and parents/guardians to the proposed diagnostic tool (algorithm) as well as their prescription.

An axillary study is also proposed the assess the cost of this intervention in the routine system in place.

   

· Field of application 

Diagnostic study

   

· Objectives

Primary objective:

  1. To assess the impact of the proposed strategies on the acute fever management practice at primary health facilities;
  2. To assess the impact of the proposed strategies on the antimalarial and antibiotic prescription practices at primary health facilities;
  3. To assess in randomized superiority diagnostic trial the curative rate whether the RDTs decisional algorithm (RDT-DA), e-Algorithm or routine system and to determine which one allow to access to quality health care at primary health facilities

Secondary objective:

  1. To assess the accuracy of an algorithm based on (i) two-step malaria RDT detecting PfHRP2/pLDH for the diagnosis of malaria infection compared to microscopy and polymerase chain reaction (PCR); (ii) and POCT for the diagnostic of bacterial infections compared to bacterial cultures.
  2. To assess the adherence of health care workers and parents/guardian to the algorithm proposed;
  3. To assess the adherence of the health care workers and parents/guardian to the prescription in RDT-DA, e-Algorithm and control arms;
  4. To assess the safety of the algorithm in the management of fever episode in febrile children presenting in outpatient clinic.
   

·Start Date 

December 2020

   

· Probable End Date 

November 2023

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