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
The current project aims to evaluate the value of the diagnostic performance of the proposed algorithm combining two-step malaria 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 the 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 allow to access to quality health cares 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/guardian to the algorithm proposed;
- To assess the adherence of the health care workers and parents/guardian 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 clinic.
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 prescriptions 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 to 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 expects to enrol randomly 1176 participant in three arms (392 per arm): e-Algorithm, decisional algorithm and control. During the reporting period, the study staffs have worked on the development of study protocol and informed consent form, which have been submitted to the ethical committees. Next to that, several project related documents including first subject approvals package, incidental findings policy, monitoring and quality assurance plans, data management plan, career development plan, disseminations and exploitation plan and study specific SOPs have been developed.
Although the Covid-19 situation has impact many activities worldwide, it has not had an impact on the progress of the e-MANIC project. The project progress is well in line with the planned activities. The next step of the project will be the study site initiation visit followed by the enrolment of the first participant.