Prospective, multicenter, observational clinical registry of pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age with suspected acute infectious meningitis. Data will be collected during hospitalization and post-discharge to evaluate clinical management, treatment and short and long-term outcomes. The study aims to generate real-world evidence on current practices and outcomes to support improvements in national care protocols.
This is a middle-income real-world prospective clinical registry study. Clinical and laboratory data will be collected during hospitalization and follow-up visits will be performed at 28, 90 and 180 days after inclusion in the study. Data collection will include empirical antibiotic therapy timing and type, time from hospital admission to antibiotic's first dose, corticosteroid therapy initiation, vaccination status per the Brazilian National Immunization Program (PNI), neurological sequelae and access to specialized rehabilitation services post-discharge. Primary outcomes will be all-cause mortality, length of hospital stay, rate of re-hospitalization and sensorineural hearing loss incidence. Secondary outcomes will be etiology-specific mortality, functional outcomes (PCPC-BR and pediatric FSS - Brazilian version), guideline-based therapies by etiology, neurological sequelae incidence stratified by etiology (e.g., motor deficits, cerebrovascular complications) , serious adverse events and access to rehabilitation. Findings will be used to inform public health system and pediatric clinical care in Brazil.
Study Type
OBSERVATIONAL
Enrollment
600
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
RECRUITINGMortality, re-hospitalization, length of hospital stay and sensory hearing loss
The primary outcome is a composite endpoint and for that a hierarchical statistical analysis of the components will be applied, considering their clinical importance and the temporal relevance between events (mortality will take precedence over the other components: incidence of all-cause re-hospitalization, length of initial hospital stay -measured in days and incidence of sensory hearing loss). The statistical methodology will include the use of the hierarchical Win Ratio and/or equivalent approaches.
Time frame: Day 28
Patients with guideline-directed therapy
Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines
Time frame: Day 180
Mortality in six months
Incidence of all-cause mortality
Time frame: Day 180
Rate of re-hospitalization
Incidence of all-cause re-hospitalization
Time frame: Day 180
Invasive ventilatory support
Incidence of invasive ventilatory support
Time frame: Day 28
Access to specialized rehabilitation services post-discharge
Proportion of patients receiving specialized rehabilitation care
Time frame: Day 28, day 90 and day 180
Length of hospitalization by etiology
Length of hospitalization (in days), stratified by infectious etiology
Time frame: Day 180
Re-hospitalization rate by etiology
Rate of unplanned re-hospitalization stratified by etiology
Time frame: Day 180
Neurological sequelae by etiology
Incidence of neurological sequelae stratified by etiology
Time frame: Day 180
Post-discharge functional neurological decline
Neurological Functional Status will be assessed using Brazilian version of the Functional Status Scale (FSS-BR): * No disability: FSS= 6 * Mild disability: FSS= 7-9 * Moderate disability: FSS= 10-15 * Severe disability: FSS= 16-21 * Very severe disability: FSS\>21
Time frame: Day 28 and day 180
Cerebral Performance Post-Meningitis
Cerebral Performance Post-Meningitis will be assessed using PCPC-BR (Pediatric Cerebral Performance Category - Brazilian version). For the purpose of this analysis, cases with a score of 6 (brain death) will be excluded here, as they will be accounted separately in the mortality outcome. * No disability: PCPC= 1 * Mild disability: PCPC= 2 * Moderate disability: PCPC= 3 * Severe disability: PCPC= 4 * Very severe disability: PCPC=5
Time frame: Day 28 and day 180
Adverse Events
Incidence of adverse events
Time frame: Day 28
Adverse outcomes by etiology
Incidence of adverse outcomes by etiology
Time frame: Day 180
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