Acute treatment and long-term follow-up of adults with infectious meningitis
Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis
This project will collect information to see how adults hospitalized with different types of infectious meningitis are treated and how they do during and after hospitalization in Brazil.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 624 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein Academic / other |
| Locations | 3 sites (Passo Fundo, Rio Grande do Sul and 2 other locations) |
| Trial ID | NCT07027475 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18 years or older hospitalized with suspected acute infectious meningitis who meet the fever plus meningeal symptom or rash inclusion criteria and consent to follow-up are eligible.
Not a fit: Patients under 18, those with non-infectious causes of meningitis, or individuals who refuse consent are unlikely to benefit directly from participation.
Why it matters
Potential benefit: If successful, the registry could help improve national treatment guidelines and reduce deaths, complications, and disability after meningitis in Brazil.
How similar studies have performed: Cohort studies and registries in high-income countries have previously informed guideline updates and improved care, but similar large-scale prospective registries are less common in middle-income settings like Brazil.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Passo Fundo, Rio Grande do Sul and 2 other locations
- Hospital São Vicente de Paulo — Passo Fundo, Rio Grande do Sul, Brazil (Recruiting)
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto, São Paulo, Brazil (Recruiting)
- Hospital Santa Marcelina — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Anna M Gomes, MD — Hospital Israelita Albert Einstein
- Study coordinator: Anna M Gomes, MD
- Email: anna.gomes@einstein.br
- Phone: +55 11 2151-1233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.