Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

NCT07027475 | Not Yet Recruiting DMC

• 1 other identifier: ATLAS-I
• Study Type: observational
• Target: 624
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, multicenter, observational clinical registry of adult patients with acute infectious meningitis across approximately 30 public and private hospitals in Brazil. The study will include adults, 18 years old and older, 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

Viral Meningitis; Bacterial Meningitis; Fungal Meningitis; Meningitis

Keywords

Meningitis; Bacterial; Viral; 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 that includes: Incidence of all-cause death Incidence of all-cause re-hospitalization Length of initial hospital stay (measured in days) Incidence of sensory hearing loss

  Day 28

Secondary Outcomes (11)

• Patients with guideline-directed therapy

  Day 180

• Mortality in six months

  Day 180

• Length of hospitalization by etiology

  Day 180

• Re-hospitalization rate

  Day 180

• Invasive ventilatory support

  Day 28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult, ≥ 18 years old, suspect 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

You may not qualify if:

• \- Refusal to provide consent for study participation

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

cerebrospinal fluid, blood (serum)

MeSH Terms

Conditions

Meningitis, Viral; Meningitis, Bacterial; Meningitis, Fungal; Meningitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Henrique A Fonseca, MD, PhD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Anna M Gomes, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M Gomes, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 18, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share