ME Dx Africa study

Context

Globally, the estimated incidence of central nervous system (CNS) viral infections is 20–30/100,000 per year, which is about three times that of bacterial infections. Local data on incidence and etiology of viral CNS infections is not available and there is no recent data on viral or fungal pathogens in infants or children.

Central nervous system (CNS) infections, including meningitis, are serious illnesses, associated with high mortality rate and devastating sequelae, in over half of all survivors. The evaluation of suspected CNS infections is complex, as clinical signs and symptoms are often not specific to the causative pathogen.

Meningitis is caused by a wide variety of pathogens or may be non-infectious in infants and children. Current practice is limited by lack of an etiological diagnosis, resulting in sub-optimal treatment and

poor outcomes, including long-term neurological sequelae. A better understanding of the causes of infectious meningitis and meningoencephalitis would facilitate treatment optimization, leading to improved outcomes for patients while reducing mortality and morbidity rates.

Objectives

The MN Africa Dx study aims at evaluating the feasibility and the clinical value of using rapid diagnostic POC* tests compared to standard of care (SoC) alone at the participant hospital sites.

The study is being implemented in three African countries, known as the African Meningitis Belt, where the burden of meningitis is the highest: Burkina Faso, Cameroon, and Côte d’Ivoire.

The randomized controlled assay aims at:

• Evaluating the diagnostic performance of the ME Panel POC compared to conventional CSF culture (gold standard).
• Documenting patterns of antimicrobials usage in the two study arms
• Performing an epidemiological survey of meningitis and encephalitis in the target population within the defined catchment areas and throughout a minimum of a yearly seasonality.
• Evaluating in participant hospitals the health-economic impact (HEOR) of the POC diagnostics intervention, taking into account that this has not been rigorously explored.
• Strengthening clinical research capacity building and diagnostics capacity building in theparticipant sites.

*A point of care test (POCT) is a diagnostic test performed in the most direct vicinity of the patient, in the doctor’s office, in pharmacies, in policlinics or medical centers, in the emergency room of certain hospitals, or even in professional laboratories, whether in a hospital or not, on the condition that the result is available within a short period of time (30 to 60 minutes). These tests are designed to be performed by personnel not necessarily trained in laboratory medicine (nurses, medical assistants), or even by the patient themselves or their relatives.