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NCT Number: NCT07062445

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

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.

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Key information

Conditions

Meningitis Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Central Nervous System Viral Diseases Fungal Meningitis Infections Meningitis, Fungal Meningitis, Viral Mycoses Nervous System Diseases Neuroinflammatory Diseases Viral Meningitis Virus Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05653-000, Brazil

Location status: Recruiting

Location contact

Henrique A R Fonseca, PhD

PRINCIPAL_INVESTIGATOR

Lucas F Theotonio dos Santos, PhD

CONTACT

[email protected]

+5511942057907

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality, re-hospitalization, length of hospital stay and sensory hearing loss

    Time frame: 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 outcomes

  1. Patients with guideline-directed therapy

    Time frame: Day 180

    Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines

  2. Mortality in six months

    Time frame: Day 180

    Incidence of all-cause mortality

  3. Rate of re-hospitalization

    Time frame: Day 180

    Incidence of all-cause re-hospitalization

  4. Invasive ventilatory support

    Time frame: Day 28

    Incidence of invasive ventilatory support

  5. Access to specialized rehabilitation services post-discharge

    Time frame: Day 28, day 90 and day 180

    Proportion of patients receiving specialized rehabilitation care

  6. Length of hospitalization by etiology

    Time frame: Day 180

    Length of hospitalization (in days), stratified by infectious etiology

  7. Re-hospitalization rate by etiology

    Time frame: Day 180

    Rate of unplanned re-hospitalization stratified by etiology

  8. Neurological sequelae by etiology

    Time frame: Day 180

    Incidence of neurological sequelae stratified by etiology

  9. Post-discharge functional neurological decline

    Time frame: 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

  10. Cerebral Performance Post-Meningitis

    Time frame: 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

  11. Adverse Events

    Time frame: Day 28

    Incidence of adverse events

  12. Adverse outcomes by etiology

    Time frame: Day 180

    Incidence of adverse outcomes by etiology

Study contacts

Contact information is provided by the study sponsor or research team.

Anna M Gomes

CONTACT

[email protected]

+55 11 2151-1233 ext. 75915

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Acronym: ATLAS-II

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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