Infectious Encephalitis
Conditions
Interventions
This is a diagnostic intervention study focused on the implementation and optimization of the BioFire FilmArray® Meningitis/Encephalitis multiplex molecular panel. The intervention consists of the pro
Sponsors
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Universidade Federal de Ciências da Saúde de Porto Alegre
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older, of any gender, who consent to participate in the study by signing an informed consent form will be included. To participate in the study, patients must present at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizure, acute focal deficit, signs of meningeal irritation, or headache, all with onset within the last 30 days and, obligatorily, pleocytosis (at least 5 leukocytes in the cerebrospinal fluid) For the control group, patients aged 18 years or older, of any gender, who were hospitalized in the SCPA with clinical syndrome of central nervous system infection with confirmatory diagnosis by cerebrospinal fluid analysis in the last four years will be included. Only patients with at least 5 cells in the cerebrospinal fluid will be included
Exclusion criteria
Exclusion criteria: Patients who do not sign the informed consent form, patients with clinical manifestations lasting more than 30 days, patients under 18 years of age, as well as patients who have undergone neurosurgery in the last 30 days, will be excluded. In the control group, patients who have undergone neurosurgery in the 30 days prior to the onset of symptoms will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the positivity rate of the BioFire® FilmArray® Meningitis/Encephalitis panel in patients with a clinical syndrome of meningitis and/or encephalitis and cerebrospinal fluid pleocytosis (= 5 cells/mm³). Verified by analyzing the panel positivity rate in the eligible population. The proportion of positive results, 95% confidence intervals, and, where applicable, diagnostic performance measures will be observed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess time to reduction or discontinuation of acyclovir in patients without proven indication of benefit. Verified by comparing antiviral duration between groups, in days.;Assess time to identification of the causative pathogen, when available. Verified by comparing the interval between cerebrospinal fluid collection and etiologic definition across groups.;Assess in-hospital mortality. Verified by comparing death rates between study groups. ;Assess the use of neuroimaging tests (brain MRI and brain CT). Verified by comparing imaging request frequencies between groups. The percentage difference in performed exams will be observed.;Assess the need for hemodialysis during hospitalization. Verified by comparing the frequency of hemodialysis indication and initiation between study groups. The proportion of patients undergoing the procedure and the absolute risk difference will be observed.;Assess the costs associated with hospitalization and therapeutic interventions. Verified by comparing direct medical costs between study groups.;Evaluate the impact of panel use on total hospital length of stay. Verified by comparing hospitalization time between study groups.;Evaluate the impact of panel use on intensive care unit (ICU) stay. Verified by comparing ICU length of stay between groups.;Assess antibiotic duration in patients with non-bacterial etiologies. Verified by comparing antibiotic therapy duration between groups in days. | — |
Countries
BR
Contacts
Public ContactAlessandro Pasqualotto
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Outcome results
None listed