Prospective, multicenter, observational clinical registry of adult patients with acute infectious meningitis across approximately 30 public and private hospitals in Brazil. The study will include adults, 18 years old and older, 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 after discharge. 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, 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 (measured by modified Rankin Score and Barthel Index 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 clinical care in Brazil.
Study Type
OBSERVATIONAL
Enrollment
624
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
The primary outcome is a composite endpoint that includes: Incidence of all-cause death Incidence of all-cause re-hospitalization Length of initial hospital stay (measured in days) Incidence of sensory hearing loss
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
Length of hospitalization by etiology
Length of hospitalization (in days), stratified by infectious etiology
Time frame: Day 180
Re-hospitalization rate
Rate 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
Proportion of patients receiving specialized rehabilitation care
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 decline
Functional status decline assessed on follow-up using Functional independence measured by modified Rankin Score ≤ 2 and Barthel Index (Brazilian version) Functional status will be assessed using two standardized measures: the Modified Rankin Score (mRS) and the Barthel Index (Brazilian version). Decline in functional independence will be categorized as follows: * Mild disability: defined by an mRS score of 0 to 2 and a Barthel Index score of 90 or higher, indicating independence or slight dependence in daily activities. * Moderate disability: defined by an mRS score of 3 and a Barthel Index score between 60 and 89, corresponding to moderate dependence requiring some assistance. * Severe disability: defined by an mRS score of 4-5 and a Barthel Index score below 60, reflecting severe dependence or bedridden status with the need for constant care.
Time frame: Day 180
Adverse Events
Incidence of adverse events
Time frame: Day 28
Adverse outcomes requiring secondary intervention by etiology
Incidence of adverse outcomes by etiology
Time frame: Day 180
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