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

February 18, 2026 updated by: Alessandro Pasqualotto, Federal University of Health Science of Porto Alegre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Irmandande Santa Casa de Porto Alegre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandro C Pasqualotto, PhD
        • Sub-Investigator:
          • Candida Driemeyer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofire FilmArray group
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
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.
No Intervention: Retrospective Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
Time Frame: At the time of BioFire® FilmArray® result availability, assessed up to 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total hospital length of stay in days
Time Frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Duration of hospitalization, measured in days, compared between study groups.
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Intensive care unit length of stay in days
Time Frame: From intensive care unit admission until intensive care unit discharge or death, whichever occurs first, assessed up to 24 months.
Duration of intensive care unit stay, measured in days, compared between study groups.
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
Time Frame: From antibiotic initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Duration of systemic antibiotic therapy, measured in days, compared between study groups in participants without confirmed bacterial etiology.
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
Time Frame: From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Duration of acyclovir therapy, measured in days, compared between study groups in participants without confirmed indication of benefit.
From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Time to pathogen identification
Time Frame: From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
Time, measured in days, from diagnostic testing to identification of an infectious pathogen, compared between study groups when a pathogen is detected.
From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
In-hospital mortality
Time Frame: From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.
Occurrence of death during hospitalization, compared between study groups.
From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.
Need for hemodialysis
Time Frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Requirement for hemodialysis at any time during hospitalization, compared between study groups.
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Direct medical costs
Time Frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Direct medical costs associated with hospitalization and therapeutic interventions, compared between study groups.
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Use of neuroimaging
Time Frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Performance of at least one brain magnetic resonance imaging or computed tomography scan during hospitalization, compared between study groups.
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Collaborators

BioMérieux
Irmandade Santa Casa de Misericórdia de Porto Alegre

Investigators

  • Study Chair: Alessandro C Pasqualotto, PhD, Federal University of Health Sciences of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

March 16, 2028

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88825625.5.0000.5335
  • U1111-1334-6700 (Other Identifier: The Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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