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.
Eligibility
Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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
* In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle.
Exclusion Criteria:
* Refusal to provide consent for study participation
Primary outcome measure(s)
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss — Day 28 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.
Trial sites (1)
Facility
City
Region
Status
Hospital Israelita Albert Einstein
São Paulo
São Paulo
Recruiting
More Hospital Israelita Albert Einstein trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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