An interventional study of Biofire FilmArray Meningitis/Encephalitis Panel in Meningitis, Encephalitic Infection and Encephalitis, sponsored by Federal University of Health Science of Porto Alegre. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Federal University of Health Science of Porto Alegre · Not applicable, Interventional, and Diagnostic
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.
This will be a prospective study, conducted at Santa Casa de Porto Alegre, a philanthropic tertiary university hospital with 1,400 beds and at Hospital Dom João Becker, which has 173 inpatient beds and 20 ICU beds. Adult patients with clinical symptoms compatible with CNS infection that began less than 30 days prior, for whom cerebrospinal fluid collection has been indicated by the attending physician, will be included. Participation in the study will be subject to the signing of an informed consent form (ICF) by the patient or their legal representative. The patient will then be included in the study. Samples will be processed with qualitative and quantitative cytology, protein, glucose, and lactate analysis, as well as specific tests as requested by the attending physician. Patients will be compared with a retrospective cohort used as a control group (patients with clinical CNS infection who underwent cerebrospinal fluid collection but were not tested with the FilmArray panel) over the past 4 years.
38 studies on the registry are indexed under Meningitis, Bacterial; 11 are open to participants now.
This study's planned enrollment of 182 is below the median of 226 across 22 interventional studies indexed under Meningitis, Bacterial.
Browse Meningitis, Bacterial studies →Federal University of Health Science of Porto Alegre is the lead sponsor of 119 studies on the registry; 20 are open to participants now.
Compared within Meningitis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Meningitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (TCLE) by the patient or their legal representative.
Exclusion Criteria:
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells/mm³) who will be prospectively tested using the BioFire FilmArray Meningitis/Encephalitis panel
Diagnostic Test: Biofire FilmArray Meningitis/Encephalitis Panel
A 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.
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.
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).
Time frame: At the time of BioFire® FilmArray® result availability, assessed up to 24 months
Total hospital length of stay in days
Duration of hospitalization, measured in days, compared between study groups.
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Intensive care unit length of stay in days
Duration of intensive care unit stay, measured in days, compared between study groups.
Time frame: 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
Duration of systemic antibiotic therapy, measured in days, compared between study groups in participants without confirmed bacterial etiology.
Time frame: 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
Duration of acyclovir therapy, measured in days, compared between study groups in participants without confirmed indication of benefit.
Time frame: From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Time to pathogen identification
Time, measured in days, from diagnostic testing to identification of an infectious pathogen, compared between study groups when a pathogen is detected.
Time frame: From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
In-hospital mortality
Occurrence of death during hospitalization, compared between study groups.
Time frame: From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.
Need for hemodialysis
Requirement for hemodialysis at any time during hospitalization, compared between study groups.
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Direct medical costs
Direct medical costs associated with hospitalization and therapeutic interventions, compared between study groups.
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Use of neuroimaging
Performance of at least one brain magnetic resonance imaging or computed tomography scan during hospitalization, compared between study groups.
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Plan to share: No — 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.
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