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

NCT07062445 | Recruiting

• 1 other identifier: ATLAS-II
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis; Bacterial Infections; Viral Meningitis; Fungal Meningitis

Keywords

meningitis; bacterial; virus; corticosteroids; antibiotics; fungal

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Patients with guideline-directed therapy

  Day 180

• Mortality in six months

  Day 180

• Rate of re-hospitalization

  Day 180

• Invasive ventilatory support

  Day 28

• Access to specialized rehabilitation services post-discharge

  Day 28, day 90 and day 180

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric population, \<17 years old, suspect of acute meningitis infection

You may qualify if:

• 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.

You may not qualify if:

• Refusal to provide consent for study participation

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05653-000, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and cerebrospinal fluid

MeSH Terms

Conditions

Meningitis; Bacterial Infections; Meningitis, Viral; Meningitis, Fungal; Virus Diseases

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Bacterial Infections and Mycoses; Infections; Central Nervous System Viral Diseases; Central Nervous System Infections; Central Nervous System Diseases; Central Nervous System Fungal Infections; Mycoses

Study Officials

• Henrique A Fonseca

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Anna M Gomes

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M Gomes

CONTACT

+55 11 2151-1233; anna.gomes@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 14, 2025
• Study Start: March 29, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)