Acute Treatment and Long-term Assessment of Adult Infectious Meningitis (ATLAS-I)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Meningitis; Bacterial Meningitis; Viral Meningitis; Fungal Meningitis

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 after discharge.

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, 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 (measured by modified Rankin Score and Barthel Index 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 clinical care in Brazil.

• Study Type: Observational
• Enrollment (Estimated): 624

Contacts and Locations

• Study Contact: Name: Anna M Gomes, MD; Phone Number: +55 11 2151-1233; Email: anna.gomes@einstein.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
      • Recruiting
      • Hospital São Vicente de Paulo
      • Contact: Aloma S Menegasso, Clinical Research Coordinator; Phone Number: +5554992216669; Email: farmaloma@hsvp.com.br
      • Principal Investigator: Alexandre P Tognon, MD, PhD
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Recruiting
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
      • Contact: Silvia F B M Negrini, Clinical Research Coordinator; Phone Number: +5516981349907; Email: sissinegrini@gmail.com
      • Principal Investigator: Rodrigo C Santana, MD, PhD
    • São Paulo, São Paulo, Brazil, 08270-070
      • Recruiting
      • Hospital Santa Marcelina
      • Contact: Carlos E Opazo, Clinical Research Coordinator; Phone Number: +5511985986136; Email: carlos.opazocpc@santamarcelina.org
      • Principal Investigator: Vanessa L da Costa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult, ≥ 18 years old, suspect acute meningitis infection

Description

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

Exclusion Criteria:

- Refusal to provide consent for study participation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with guideline-directed therapy	Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines	Day 180
Mortality in six months	Incidence of all-cause mortality	Day 180
Length of hospitalization by etiology	Length of hospitalization (in days), stratified by infectious etiology	Day 180
Re-hospitalization rate	Rate of all-cause re-hospitalization	Day 180
Invasive ventilatory support	Incidence of invasive ventilatory support	Day 28
Access to specialized rehabilitation services	Proportion of patients receiving specialized rehabilitation care	Day 180
Re-hospitalization rate by etiology	Rate of unplanned re-hospitalization stratified by etiology	Day 180
Neurological sequelae by etiology	Incidence of neurological sequelae stratified by etiology	Day 180
Post-discharge functional decline	Functional status decline assessed on follow-up using Functional independence measured by modified Rankin Score ≤ 2 and Barthel Index (Brazilian version) Functional status will be assessed using two standardized measures: the Modified Rankin Score (mRS) and the Barthel Index (Brazilian version). Decline in functional independence will be categorized as follows: Mild disability: defined by an mRS score of 0 to 2 and a Barthel Index score of 90 or higher, indicating independence or slight dependence in daily activities.; Moderate disability: defined by an mRS score of 3 and a Barthel Index score between 60 and 89, corresponding to moderate dependence requiring some assistance.; Severe disability: defined by an mRS score of 4-5 and a Barthel Index score below 60, reflecting severe dependence or bedridden status with the need for constant care.	Day 180
Adverse Events	Incidence of adverse events	Day 28
Adverse outcomes requiring secondary intervention by etiology	Incidence of adverse outcomes by etiology	Day 180

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Ministry of Health, Brazil
• Investigators: Study Chair: Henrique A Fonseca, MD, PhD, Hospital Israelita Albert Einstein; Principal Investigator: Anna M Gomes, MD, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: June 16, 2025
• First Posted (Actual): June 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Antibiotics; Meningitis; Viral; Corticosteroids; Bacterial; Fungal
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Virus Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Viral Diseases; Central Nervous System Infections; Central Nervous System Fungal Infections; Mycoses; Central Nervous System Bacterial Infections; Meningitis; Meningitis, Bacterial; Meningitis, Viral; Meningitis, Fungal
• Other Study ID Numbers: ATLAS-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No