Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis/Encephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.
2 other identifiers
interventional
182
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
February 25, 2026
February 1, 2026
2 years
February 1, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
Proportion of positive BioFire® FilmArray® Meningitis/Encephalitis panel results among participants presenting with a clinical syndrome of meningitis and/or encephalitis and cerebrospinal fluid pleocytosis (≥ 5 cells/mm³).
At the time of BioFire® FilmArray® result availability, assessed up to 24 months
Secondary Outcomes (9)
Total hospital length of stay in days
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Intensive care unit length of stay in days
From intensive care unit admission until intensive care unit discharge or death, whichever occurs first, assessed up to 24 months.
Duration of antibiotic therapy in participants without confirmed bacterial infection
From antibiotic initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Duration of acyclovir therapy in participants without confirmed indication
From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Time to pathogen identification
From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
- +4 more secondary outcomes
Study Arms (2)
Biofire FilmArray group
EXPERIMENTALPatients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells/mm³) who will be prospectively tested using the BioFire FilmArray Meningitis/Encephalitis panel
Retrospective Control Group
NO INTERVENTIONA retrospective cohort of patients from the last four years who presented with similar clinical syndromes and CSF pleocytosis (≥ 5 cells/mm³) but were managed with standard care without molecular panel testing.
Interventions
The Biofire FilmArray is a multiplex molecular diagnostic test that will be performed on 0.2 mL of cerebrospinal fluid (CSF) collected from patients via lumbar or suboccipital puncture. The system automatically performs DNA/RNA extraction, purification, multiplex PCR, and identification of 14 different pathogens (6 bacteria, 7 viruses, and 1 fungus). The complete process takes approximately one hour and provides qualitative results to guide therapeutic decisions such as antibiotic stewardship.
Eligibility Criteria
You may qualify if:
- Patients aged 18 years or older, of any gender.
- Presence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.
- Symptoms must have started within the last 30 days.
- Obligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells/mm³).
- Provision of written Informed Consent (TCLE) by the patient or their legal representative.
You may not qualify if:
- Failure to sign the Informed Consent Form.
- Clinical manifestations lasting more than 30 days.
- Patients under 18 years of age.
- Patients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Irmandande Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Related Publications (4)
Cailleaux M, Pilmis B, Mizrahi A, Lourtet-Hascoet J, Nguyen Van JC, Alix L, Couzigou C, Vidal B, Tattevin P, Le Monnier A. Impact of a multiplex PCR assay (FilmArray(R)) on the management of patients with suspected central nervous system infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):293-297. doi: 10.1007/s10096-019-03724-7. Epub 2019 Nov 12.
PMID: 31720944BACKGROUNDDuff S, Hasbun R, Balada-Llasat JM, Zimmer L, Bozzette SA, Ginocchio CC. Economic analysis of rapid multiplex polymerase chain reaction testing for meningitis/encephalitis in adult patients. Infection. 2019 Dec;47(6):945-953. doi: 10.1007/s15010-019-01320-7. Epub 2019 May 20.
PMID: 31111325BACKGROUNDSoucek DK, Dumkow LE, VanLangen KM, Jameson AP. Cost Justification of the BioFire FilmArray Meningitis/Encephalitis Panel Versus Standard of Care for Diagnosing Meningitis in a Community Hospital. J Pharm Pract. 2019 Feb;32(1):36-40. doi: 10.1177/0897190017737697. Epub 2017 Nov 1.
PMID: 29092659BACKGROUNDTrujillo-Gomez J, Tsokani S, Arango-Ferreira C, Atehortua-Munoz S, Jimenez-Villegas MJ, Serrano-Tabares C, Veroniki AA, Florez ID. Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis. EClinicalMedicine. 2022 Feb 14;44:101275. doi: 10.1016/j.eclinm.2022.101275. eCollection 2022 Feb.
PMID: 35198914BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alessandro C Pasqualotto, PhD
Federal University of Health Sciences of Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the infectious diseases department and the molecular biology laboratory
Study Record Dates
First Submitted
February 1, 2026
First Posted
February 25, 2026
Study Start
March 16, 2026
Primary Completion (Estimated)
March 16, 2028
Study Completion (Estimated)
October 31, 2029
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared to ensure strict compliance with the Brazilian General Data Protection Law (LGPD) and to protect the privacy of participants, especially those from the retrospective cohort for whom a waiver of informed consent was granted due to the impossibility of contact.