Last Updated: 12/06/2024

Development and evaluation of an electronic algorithm using malaria rapid diagnostic tests detecting PfHRP2 and pLDH for the management of febrile illness in children under 5 years attending outpatient facilities in Burkina Faso (e-MANIC)

Objectives

The current project aims to evaluate the value of the diagnostic performance of the proposed algorithm combining two-step malaria rapid diagnostic tests (RDT) detecting PfHRP2/pLDH and POCT for the diagnostic of malaria and bacterial infections respectively, in the management of febrile illnesses in children from 6 to 59 months in a process of Universal Health Coverage (UHC).

Specific objectives are:

  • To assess the impact of the proposed strategies on acute fever management practices at primary health facilities;
  • To assess the impact of the proposed strategies on the antimalarial and antibiotic prescription practices at primary health facilities;
  • 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 allows access to quality health care at primary health facilities;
  • To assess the accuracy of the 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;
  • To assess the adherence of health care workers and parents/guardians to the algorithm proposed;
  • To assess the adherence of the health care workers and parents/guardians to the prescription in RDT-DA, e-Algorithm, and control arms; and
  • To assess the safety of the algorithm in the management of febrile cases in children presenting in outpatient clinics.
Principal Investigators / Focal Persons

Francois Kiemde

Rationale and Abstract

In Sub-Saharan Africa (SSA), febrile illnesses remain a major public health problem in children. The introduction of malaria rapid diagnostic tests (RDTs) in routine healthcare has greatly improved the management of malaria. However, despite the good attitude of healthcare workers to adhere to malaria RDT results, persisting hrp2 antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescription practices. These limitations of the RDTs lead to poor management of febrile diseases and antimicrobial resistance (AMR). To improve the diagnosis of these febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH combined with point-of-care (PoC) tests for C-reactive protein (CRP), white blood cells (WBC) count, urine dipstick, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR. 

The study randomly enrolled 1176 participants in three arms (392 per arm): e-Algorithm, decisional algorithm, and control. During the reporting period, the study staff worked on the development of the study protocol and informed consent form, which were submitted to the ethical committees. Next to that, several project-related documents including the first subject approvals package, incidental findings policy, monitoring and quality assurance plans, data management plan, career development plan, dissemination and exploitation plan, and study-specific SOPs were developed.

Study Design

Study type: Interventional

Primary purpose: Diagnostic evaluation

Enrollment: 1176 participants

Allocation: Randomized

Interventional Model: Parallel Assignment

Masking: None (Open Label)

NCT number: NCT05285657

 

Date

Dec 2020 — Nov 2023

Total Project Funding

$178,775

Funding Details
European and Developing Countries Clinical Trials Partnership (EDCTP), The Netherlands

Career Development Fellowship-2019
Grant ID: TMA2019CDF-2697
EUR 149,425
Project Site

Burkina Faso

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