Algorithm Using a Rapid Diagnostic Test for the Management of Childhood Febrile Diseases.

Summary

In Sub-Saharan Africa (SSA), fever remains 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 test results, persisting hrp2antigen and low sensitivity of pLDH RDT negatively affect antimalarials and antibiotics prescriptions practices. This is one of the main causes of antimicrobial resistance (AMR) and inappropriate management of febrile diseases. To improve the diagnosis of febrile diseases and subsequent prescription of antimicrobials, it is hypothesized that the implementation of an algorithm including a two-step malaria RDT PfHRP2/pLDH supported by point-of-care tests (POCTs) for C-reactive protein, oximetry, and bacterial infection such as Group A Streptococcus, and Salmonella/Shigella, will significantly improve the management of febrile diseases and thereby tackling AMR.

To assess the value of the proposed algorithm, an open-label randomized controlled trial with three arms, enrolling febrile children under 5 years is proposed.

* In the control arm, febrile children will benefit from a complete clinical examination. Treatment will be done according to the national guideline.
* In RDTs decisional algorithm (RDT-DA) arm (intervention), the complete clinical examination will be supported by two-step malaria RDT and bacterial infections RDTs. Prescription will be left to the discretion of the healthcare workers.
* In e-algorithm arm (intervention), the complete clinical examination and the outcomes of RDTs (malaria and bacterial infections) will be digitalized. Diagnostic and prescription will be done by the algorithm.

A final follow-up visit (day7) will be scheduled for all participants. Patients will be asked to return to the health facilities in case of no improvement.

Primary study outcomes will be the proportion of curative case and antimicrobial(s) prescribed in each arm. Secondary outcomes include: (i) adherence of healthcare workers to the algorithm; (ii) adherence of parents/guardian to treatment; (iii) accuracy of the algorithm for the diagnostic of malaria.

This project will serve as a path of policy change in the management of febrile diseases and AMR. By relying on existing RDTs available, the implementation of this algorithm will tackle AMR and provide better care. If successful, the project will equip the lead applicant to establish himself as an independent researcher with ability to further build his own research team. The project will also offer training opportunities to young scientists, and further strengthen already existing capacities of the home institute.

Conditions

• Antimicrobial Resistance

Interventions

DIAGNOSTIC_TEST

Two-step malaria RDT detecting PfHRP2/pLDH (SD Ag Bioline Malaria Ag P.f/Pan: Standard Diagnostics, Hagal-Dong, Korea)

The interpretation of the two-step malaria RDT will be done as follow: * PfHRP2(+)/pLDH(+): falciparum malaria or co-infection with non-falciparum malaria; * PfHRP2(-)/pLDH(+): non-falciparum malaria or falciparum malaria with deletion of hrp2; * PfHRP2(-)/pLDH(-): negative results * PfHRP2(+)/pLDH(-): inconclusive results and information on previous antimalarial treatment is needed to differentiate: Within the past 28 days: * If previous antimalarial treatment is reported, the malaria diagnosis is reported as negative result. Nonetheless, the antimalarial treatment decision will be based on malaria microscopy; * If previous antimalarial treatment is not reported, the malaria diagnosis is reported as positive result. Other PoC tests for bacterial infections The two-step malaria RDT will be supported by PoC test listed above to diagnose bacterial or viral infection in all patients.

Sponsors & Collaborators

• Institut de Recherche en Sciences de la Sante, Burkina Faso

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2022-02-28

Completion

2023-11-30

Countries

• Burkina Faso

Study Locations