Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

NCT07027475 | Recruiting DMC

• 1 other identifier: ATLAS-I
• Study Type: observational
• Target: 624
• Locations: 1 country
• Sites: 6

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; Meningitis; Fungal Meningitis

Keywords

Meningitis; Bacterial; Viral; Corticosteroids; Antibiotics; Fungal

Outcome Measures

Primary Outcomes (1)

• Mortality

  The primary outcome is the incidence of all-cause death

  Day 28

Secondary Outcomes (16)

• Re-hospitalization

  Day 28

• Length of hospital stay

  Day 28

• Invasive ventilatory support

  Day 28

• Adverse Events

  Day 28

• First dose of antibiotic therapy

  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:

• Both sexes, aged ≥ 18 years, meeting one or more of the criteria (A, B or C) below:
• \> Criterion A: Clinical presentation compatible with a suspected case of meningitis or meningococcal disease:
• Fever ≥ 37.8 °C (axillary) associated with at least two of the following:
• Severe headache
• Vomiting
• Altered level of consciousness (confusion, drowsiness, irritability)
• Photophobia
• Seizure OR Fever associated with one of the classic signs of meningeal irritation (neck stiffness, Kernig or Brudzinski signs) OR Sudden-onset fever with petechial rash or hemorrhagic suffusions
• Criterion B: Cerebrospinal fluid with leukocytes ≥ 5 cells/mm³ (corrected for red blood cell count at 1:500)
• Criterion C: Confirmed etiological diagnosis of meningitis or meningococcal disease with no more than 48 hours between pathogen confirmation and signature of the informed consent form by the participant or legal representative.

You may not qualify if:

• Refusal to provide consent for the study.
• Presence of a neurological condition, other than meningitis, that accounts for the current clinical picture.
• Clinical, laboratory or radiological evidence of an alternative infectious focus that accounts for the current clinical picture.
• Etiological diagnosis of meningitis or meningococcal disease confirmed more than 48 hours earlier.

Sponsors & Collaborators

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

Study Sites (6)

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

ACTIVE NOT RECRUITING

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

RECRUITING

Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, 14051-140, Brazil

RECRUITING

Hospital Municipal Dr Moysés Deutsch - M'Boi Mirim

São Paulo, 04905020, Brazil

RECRUITING

Hospital Santa Marcelina

São Paulo, 08270-070, Brazil

RECRUITING

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, 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: March 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)