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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality, 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with guideline-directed therapy | Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines | Day 180 |
| Mortality in six months |
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Inclusion Criteria:
Fever (axillary temperature ≥37.8°C) followed by two or more of the following symptoms*: severe headache, vomiting, altered consciousness (confusion, drowsiness, or irritability), photophobia (increased sensitivity to light), presence of seizures OR
Fever accompanied by at least one meningeal irritation sign, such as neck stiffness, Kernig's sign, or Brudzinski's sign OR
Sudden onset of fever and appearance of petechial skin rash or hemorrhagic suffusions
Exclusion Criteria:
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Pediatric population, <17 years old, suspect of acute meningitis infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna M Gomes | Contact | +55 11 2151-1233 | 75915 | anna.gomes@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Henrique A Fonseca | Hospital Israelita Albert Einstein | Study Chair |
| Anna M Gomes | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | Recruiting | São Paulo | São Paulo | 05653-000 | Brazil |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| D001424 | Bacterial Infections |
| D008587 | Meningitis, Viral |
| D016921 | Meningitis, Fungal |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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serum and cerebrospinal fluid
Incidence of all-cause mortality
| Day 180 |
| Rate of re-hospitalization | Incidence of all-cause re-hospitalization | Day 180 |
| Invasive ventilatory support | Incidence of invasive ventilatory support | Day 28 |
| Access to specialized rehabilitation services post-discharge | Proportion of patients receiving specialized rehabilitation care | Day 28, day 90 and day 180 |
| Length of hospitalization by etiology | Length of hospitalization (in days), stratified by infectious etiology | Day 180 |
| Re-hospitalization rate by etiology | Rate of unplanned re-hospitalization stratified by etiology | Day 180 |
| Neurological sequelae by etiology | Incidence of neurological sequelae stratified by etiology | Day 180 |
| Post-discharge functional neurological decline | Neurological Functional Status will be assessed using Brazilian version of the Functional Status Scale (FSS-BR):
| 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.
| Day 28 and day 180 |
| Adverse Events | Incidence of adverse events | Day 28 |
| Adverse outcomes by etiology | Incidence of adverse outcomes by etiology | Day 180 |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |