Bacterial Infections, Fungal Meningitis, Meningitis, Viral Meningitis
Conditions
Keywords
meningitis, bacterial, virus, corticosteroids, antibiotics, fungal
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.
Interventions
None listed
Sponsors
Hospital Israelita Albert Einstein
Ministry of Health, Brazil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of re-hospitalization | Day 180 | Incidence of all-cause re-hospitalization |
| Invasive ventilatory support | Day 28 | Incidence of invasive ventilatory support |
| Access to specialized rehabilitation services post-discharge | Day 28, day 90 and day 180 | Proportion of patients receiving specialized rehabilitation care |
| Length of hospitalization by etiology | Day 180 | Length of hospitalization (in days), stratified by infectious etiology |
| Re-hospitalization rate by etiology | Day 180 | Rate of unplanned re-hospitalization stratified by 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 |
Countries
Brazil
Contacts
CONTACTAnna M Gomes
STUDY_CHAIRHenrique A Fonseca
Hospital Israelita Albert Einstein
PRINCIPAL_INVESTIGATORAnna M Gomes
Hospital Israelita Albert Einstein
Outcome results
None listed