Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Hospital Israelita Albert Einstein624 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

624

Conditions

Viral Meningitis Bacterial Meningitis Fungal Meningitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

ACTIVE_NOT_RECRUITING

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, Brazil

RECRUITING

Hospital Santa Marcelina

São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

Mortality

The primary outcome is the incidence of all-cause death

Time frame: Day 28

Secondary Outcomes

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

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Overview

Conditions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts