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 outcome will be all-cause mortality. Secondary outcomes will be length of hospital stay, rate of re- hospitalization, sensorineural hearing loss incidence, 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), adverse events, incidence of use of post-meningitis assistive devices 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
  • 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
  • São Paulo, Brazil, 04905020
    • Recruiting
    • Hospital Municipal Dr Moysés Deutsch - M'Boi Mirim
    • Contact: RAFAELA A ALQUERES, MD; Phone Number: +5511961947957
    • Contact: Edmilson Carvalho; Phone Number: +5511984777507; Email: edmilson.carvalho@einstein.br
  • Ceará
    • Fortaleza, Ceará, Brazil
      • Active, not recruiting
      • Hospital Universitário Walter Cantídio
  • 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
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
      • Recruiting
      • Hospitalar Moinhos de Vento
      • Contact: Giovanna Antunes; Phone Number: +55 51 33143209; Email: regulatorio.pesquisa@hmv.org.br
      • Contact: Thais L Secchi, MD, MSc; Phone Number: +55 51 998977789; Email: contato.pesquisaclinica@hmv.org.br
      • Principal Investigator: Thais L Secchi, MD, MSc
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Recruiting
      • Hospital Das Clinicas 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

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:

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.

Exclusion criteria

• 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.
• Use of an intraventricular device prior to study inclusion.
• Etiological diagnosis of meningitis or meningococcal disease confirmed more than 48 hours earlier.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The primary outcome is the incidence of all-cause death	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
Re-hospitalization	Incidence of all-cause re-hospitalization	Day 28
Length of hospital stay	Length of initial hospital stay (measured in days)	Day 28
First dose of antibiotic therapy	Time from hospital admission to administration of the first dose of antibiotic therapy	Day 28
Sensory hearing loss	Incidence of sensory hearing loss	Day 28
Post-meningitis assistive devices	Incidence of use of post-meningitis assistive devices (hearing aid; ambulation support - wheelchair, walker; nasoenteral tube or gastrostomy; ventilatory support; limb prosthesis; low-vision assistive device; cerebrospinal fluid shunt device);	Day 180

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Anna M Gomes, MD, Hospital Israelita Albert Einstein; Study Chair: Henrique A Fonseca, PhD, 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): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 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