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Recruiting NCT07027475

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Observational Viral Meningitis Bacterial Meningitis Fungal Meningitis Meningitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Viral Meningitis, Bacterial Meningitis, Fungal Meningitis, Meningitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Mortality, re-hospitalization, length of hospital stay and sensory hearing loss [Time frame: Day 28]
Secondary outcome measures (11)
  • Patients with guideline-directed therapy [Time frame: Day 180]
  • Mortality in six months [Time frame: Day 180]
  • Length of hospitalization by etiology [Time frame: Day 180]
  • Re-hospitalization rate [Time frame: Day 180]
  • Invasive ventilatory support [Time frame: Day 28]
  • Access to specialized rehabilitation services [Time frame: Day 180]
  • Re-hospitalization rate by etiology [Time frame: Day 180]
  • Neurological sequelae by etiology [Time frame: Day 180]
  • Post-discharge functional decline [Time frame: Day 180]
  • Adverse Events [Time frame: Day 28]
  • Adverse outcomes requiring secondary intervention by etiology [Time frame: Day 180]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 3 centers
  • Hospital São Vicente de Paulo — Passo Fundo
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto
  • Hospital Santa Marcelina — São Paulo

Identifiers

NCT: NCT07027475 · ATLAS-I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗