NCT Number: NCT07432113
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Alessandro C Pasqualotto, PhD
CONTACT
Alessandro C Pasqualotto, PhD
PRINCIPAL_INVESTIGATOR
Candida Driemeyer, MD
CONTACT
Candida Driemeyer, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Alessandro C Pasqualotto, PhD
CONTACT
Cândida Driemeyer, MD
CONTACT
Federal University of Health Science of Porto Alegre
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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