Acute treatment and long-term follow-up of adults with infectious meningitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational registry will enroll adults (≥18 years) with suspected infectious meningitis across about 30 public and private hospitals in Brazil. Clinical and laboratory data will be collected during hospitalization and at post-discharge visits to document treatments such as timing and type of empirical antibiotics, corticosteroid use, vaccination status, and access to rehabilitation. Primary outcomes include all-cause mortality, length of hospital stay, rehospitalization rate, and incidence of sensorineural hearing loss, while secondary outcomes cover etiology-specific mortality, functional measures (modified Rankin Scale and Barthel Index), guideline concordance, neurological sequelae, and serious adverse events. The registry aims to generate real-world evidence to inform national public health policy and clinical care pathways for meningitis in Brazil.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital São Vicente de Paulo
  Passo Fundo, Rio Grande do Sul, Brazil Recruiting
• Hospitalar Moinhos de Vento
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
  Ribeirão Preto, São Paulo, Brazil Recruiting
• Hospital Municipal Dr Moysés Deutsch - M'Boi Mirim
  São Paulo, São Paulo, Brazil Recruiting
• Hospital Santa Marcelina
  São Paulo, São Paulo, Brazil Recruiting
• Hospital Universitário Walter Cantídio
  Fortaleza, Ceará, Brazil Active not recruiting

Study contacts

• Principal investigator: Lucas F Theotonio dos Santos, PhD — Hospital Israelita Albert Einstein
• Study coordinator: Lucas F Theotonio dos Santos, PhD
• Email: lucas.theotonio@einstein.br
• Phone: +55 11 2151-1233

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.