Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1334-6700 | Other Identifier | The Universal Trial Number (UTN) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | OTHER |
| BioMérieux | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biofire FilmArray group | Experimental | 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 |
|
| Retrospective Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofire FilmArray Meningitis/Encephalitis Panel | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospital length of stay in days | 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 |
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro C Pasqualotto, PhD | Contact | +55 51 999951614 | pasqualotto@ufcspa.edu.br | |
| Cândida Driemeyer, MD | Contact | +5551998793442 | driemeyer@ufcspa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro C Pasqualotto, PhD | Federal University of Health Sciences of Porto Alegre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandande Santa Casa de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31720944 | Background | 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. | |
| 31111325 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
The data obtained in the prospective arm of the study will be compared with those of a control group formed by a retrospective cohort of patients hospitalized in the last four years, with compatible clinical syndrome and liquid containing hair less than 5 cells. These data are previously collected as part of routine medical care and are recorded in the medical records of the participating institutions. There will be no direct interaction with the participants and no additional collection of information or biological materials.
Not provided
Not provided
Not provided
Not provided
|
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 | 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 | 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, 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 | 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 | 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 | 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 | 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. |
| Duff 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. |
| 29092659 | Background | Soucek 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. |
| 35198914 | Background | Trujillo-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. |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D004660 | Encephalitis |
| D016921 | Meningitis, Fungal |
| D008587 | Meningitis, Viral |
| D016920 | Meningitis, Bacterial |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D002494 | Central Nervous System Infections |
| D020805 | Central Nervous System Viral Diseases |
| D014777 | Virus Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided