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NCT Number: NCT07027475

Acute Treatment and Long-term Assessment of Adult Infectious 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality, re-hospitalization, length of hospital stay and sensory hearing loss

    Time frame: Day 28

    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

Secondary outcomes

  1. Patients with guideline-directed therapy

    Time frame: Day 180

    Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines

  2. Mortality in six months

    Time frame: Day 180

    Incidence of all-cause mortality

  3. Length of hospitalization by etiology

    Time frame: Day 180

    Length of hospitalization (in days), stratified by infectious etiology

  4. Re-hospitalization rate

    Time frame: Day 180

    Rate of all-cause re-hospitalization

  5. Invasive ventilatory support

    Time frame: Day 28

    Incidence of invasive ventilatory support

  6. Access to specialized rehabilitation services

    Time frame: Day 180

    Proportion of patients receiving specialized rehabilitation care

  7. Re-hospitalization rate by etiology

    Time frame: Day 180

    Rate of unplanned re-hospitalization stratified by etiology

  8. Neurological sequelae by etiology

    Time frame: Day 180

    Incidence of neurological sequelae stratified by etiology

  9. Post-discharge functional decline

    Time frame: Day 180

    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.
  10. Adverse Events

    Time frame: Day 28

    Incidence of adverse events

  11. Adverse outcomes requiring secondary intervention by etiology

    Time frame: Day 180

    Incidence of adverse outcomes by etiology

Study contacts

Contact information is provided by the study sponsor or research team.

Anna M Gomes, MD

CONTACT

[email protected]

+55 11 2151-1233

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: ATLAS-I

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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