An observational study in Viral Meningitis, Bacterial Meningitis and Fungal Meningitis, sponsored by Hospital Israelita Albert Einstein. Recruiting at 6 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Hospital Israelita Albert Einstein · Observational
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.
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 outcome will be all-cause mortality. Secondary outcomes will be length of hospital stay, rate of re- hospitalization, sensorineural hearing loss incidence, 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), adverse events, incidence of use of post-meningitis assistive devices and access to rehabilitation.
Findings will be used to inform public health system and clinical care in Brazil.
38 studies on the registry are indexed under Meningitis, Bacterial; 11 are open to participants now.
This study's planned enrollment of 624 is above the median of 555 across 15 observational studies indexed under Meningitis, Bacterial.
Browse Meningitis, Bacterial studies →Hospital Israelita Albert Einstein is the lead sponsor of 147 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult, ≥ 18 years old, suspect acute meningitis infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Mortality
The primary outcome is the incidence of all-cause death
Time frame: Day 28
Re-hospitalization
Incidence of all-cause re-hospitalization
Time frame: Day 28
Length of hospital stay
Length of initial hospital stay (measured in days)
Time frame: Day 28
Invasive ventilatory support
Incidence of invasive ventilatory support
Time frame: Day 28
Adverse Events
Incidence of adverse events
Time frame: Day 28
First dose of antibiotic therapy
Time from hospital admission to administration of the first dose of antibiotic therapy
Time frame: Day 28
Sensory hearing loss
Incidence of sensory hearing loss
Time frame: Day 28
Patients with guideline-directed therapy
Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines
Time frame: Day 180
Mortality in six months
Incidence of all-cause mortality
Time frame: Day 180
Length of hospitalization by etiology
Length of hospitalization (in days), stratified by infectious etiology
Time frame: Day 180
Re-hospitalization rate
Rate of all-cause re-hospitalization
Time frame: Day 180
Access to specialized rehabilitation services
Proportion of patients receiving specialized rehabilitation care
Time frame: Day 180
Re-hospitalization rate by etiology
Rate of unplanned re-hospitalization stratified by etiology
Time frame: Day 180
Neurological sequelae by etiology
Incidence of neurological sequelae stratified by etiology
Time frame: Day 180
Post-discharge functional decline
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.
Time frame: Day 180
Adverse outcomes requiring secondary intervention by etiology
Incidence of adverse outcomes by etiology
Time frame: Day 180
Post-meningitis assistive devices
Incidence of use of post-meningitis assistive devices (hearing aid; ambulation support - wheelchair, walker; nasoenteral tube or gastrostomy; ventilatory support; limb prosthesis; low-vision assistive device; cerebrospinal fluid shunt device);
Time frame: Day 180
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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