Bacterial Meningitis, Fungal Meningitis, Meningitis, Viral Meningitis
Conditions
Keywords
Meningitis, Bacterial, Viral, Corticosteroids, Antibiotics, Fungal
Brief summary
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 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.
Interventions
None listed
Sponsors
Hospital Israelita Albert Einstein
Ministry of Health, Brazil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Day 28 | The primary outcome is the incidence of all-cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-hospitalization | Day 28 | Incidence of all-cause re-hospitalization |
| Length of hospital stay | Day 28 | Length of initial hospital stay (measured in days) |
| Invasive ventilatory support | Day 28 | Incidence of invasive ventilatory support |
| Adverse Events | Day 28 | Incidence of adverse events |
| First dose of antibiotic therapy | Day 28 | Time from hospital admission to administration of the first dose of antibiotic therapy |
| Sensory hearing loss | Day 28 | Incidence of sensory hearing loss |
| Patients with guideline-directed therapy | Day 180 | Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines |
| Mortality in six months | Day 180 | Incidence of all-cause mortality |
| Length of hospitalization by etiology | Day 180 | Length of hospitalization (in days), stratified by infectious etiology |
| Re-hospitalization rate | Day 180 | Rate of all-cause re-hospitalization |
| Access to specialized rehabilitation services | Day 180 | Proportion of patients receiving specialized rehabilitation care |
| Re-hospitalization rate by etiology | Day 180 | Rate of unplanned re-hospitalization stratified by etiology |
| Neurological sequelae by etiology | Day 180 | Incidence of neurological sequelae stratified by etiology |
| Post-discharge functional decline | Day 180 | 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. |
| Adverse outcomes requiring secondary intervention by etiology | Day 180 | Incidence of adverse outcomes by etiology |
| Post-meningitis assistive devices | Day 180 | 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); |
Countries
Brazil
Contacts
CONTACTAnna M Gomes, MD
STUDY_CHAIRHenrique A Fonseca, PhD
Hospital Israelita Albert Einstein
PRINCIPAL_INVESTIGATORAnna M Gomes, MD
Hospital Israelita Albert Einstein
Outcome results
None listed