Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis/Encephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of Health Science of Porto Alegre

About this trial

Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.

Objective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis/Encephalitis panel in patients with clinical syndrome of meningitis and/or encephalitis and pleocytosis (CSF ≥ 5 cells).

As secondary objectives, the study aims to:

Determine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.

Compare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.

Compare the time for identification of the causative pathogen and mortality rates between the study groups.

Perform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.

Methods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.

Eligibility criteria

Qualifiers

None

Disqualifiers

Failure to sign the Informed Consent Form.

Trial design

Treatments tested in this trial

  • Biofire FilmArray Meningitis/Encephalitis Panel

Treatment groups

182 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Federal University of Health Science of Porto Alegre

Lead sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Collaborator

BioMérieux

Collaborator