Actively Recruiting

Age: 18Years +
All Genders
ID07027475

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

Led by Hospital Israelita Albert Einstein · Updated on 2026-05-07

624

Participants Needed

3

Research Sites

8 weeks

Total Duration

On this page

Sponsors

H

Hospital Israelita Albert Einstein

Lead Sponsor

M

Ministry of Health, Brazil

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, multicenter observational clinical registry involving adult patients aged 18 and older with suspected acute infectious meningitis, across about 30 public and private hospitals in Brazil. The study aims to gather real-world evidence on current clinical management, treatments, and both short- and long-term outcomes to support improvements in national care protocols. It focuses on meningitis caused by viral, bacterial, or fungal infections. Clinical and laboratory data will be collected during hospitalization and through follow-up visits after discharge. The data include timing and type of empirical antibiotic therapy, time from hospital admission to first antibiotic dose, corticosteroid therapy initiation, vaccination status according to the Brazilian National Immunization Program, neurological complications, and access to specialized rehabilitation services post-discharge. The study will assess outcomes such as mortality, hospital stay length, re-hospitalization rates, and sensorineural hearing loss. Participants will be monitored closely during hospitalization and after discharge, with data collection aimed at evaluating functional status through measures like the modified Rankin Score and Barthel Index. Researchers will track serious adverse events, neurological sequelae, and rehabilitation access over a period extending up to 180 days. This comprehensive follow-up will help inform public health and clinical care improvements in Brazil.

CONDITIONS

Brief Title

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Fever (axillary temperature 6537.8�b0C) with two or more symptoms: severe headache, vomiting, altered consciousness, photophobia, or seizures
  • Fever with at least one meningeal irritation sign such as neck stiffness, Kernig's sign, or Brudzinski's sign
  • Sudden fever onset with petechial skin rash or hemorrhagic suffusions
  • Willingness to provide consent for study participation
Not Eligible

You will not qualify if you...

  • Refusal to provide consent for study participation

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Duration of hospitalization

Participants are observed during hospitalization with collection of clinical and laboratory data related to empirical antibiotic therapy, corticosteroid therapy, and vaccination status.

Visits during hospitalization as per routine care

Long-term Monitoring

Duration - Up to 6 months after discharge

Participants are followed after discharge to assess outcomes including mortality, length of hospital stay, re-hospitalization, neurological sequelae, hearing loss, functional status, and access to rehabilitation services.

Follow-up visits up to Day 180 after discharge

Trial Site Locations

Total: 3 locations

1

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil, 99010-080

Actively Recruiting

2

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil, 14051-140

Actively Recruiting

3

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil, 08270-070

Actively Recruiting

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Research Team

A

Anna M Gomes, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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