Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis

Not yet recruiting

• Conditions: Meningitis; Bacterial Infections; Viral Meningitis; Fungal Meningitis

• Registration Number: NCT07062445
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-08-01
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Invasive ventilatory support	Day 28	Incidence of invasive ventilatory support
Patients with guideline-directed therapy	Day 180	Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines
Mortality in six months	Day 180	Incidence of all-cause mortality
Length of hospitalization by etiology	Day 180	Length of hospitalization (in days), stratified by infectious etiology
Neurological sequelae by etiology	Day 180	Incidence of neurological sequelae stratified by etiology
Post-discharge functional neurological decline	Day 28 and day 180	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
Cerebral Performance Post-Meningitis	Day 28 and day 180	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
Adverse Events	Day 28	Incidence of adverse events
Adverse outcomes by etiology	Day 180	Incidence of adverse outcomes by etiology
Rate of re-hospitalization	Day 180	Incidence of all-cause re-hospitalization
Re-hospitalization rate by etiology	Day 180	Rate of unplanned re-hospitalization stratified by etiology
Access to specialized rehabilitation services post-discharge	Day 28, day 90 and day 180	Proportion of patients receiving specialized rehabilitation care