Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Not yet recruiting

• Conditions: Viral Meningitis; Bacterial Meningitis; Fungal Meningitis; Meningitis

• Registration Number: NCT07027475
• Lead Sponsor: Hospital Israelita Albert Einstein

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 outcomes will be all-cause mortality, length of hospital stay, rate of re- hospitalization and sensorineural hearing loss incidence.

Secondary outcomes will be 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) , serious adverse events and access to rehabilitation.

Findings will be used to inform public health system and clinical care in Brazil.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-08
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 624

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss	Day 28	The primary outcome is a composite endpoint that includes: Incidence of all-cause death Incidence of all-cause re-hospitalization Length of initial hospital stay (measured in days) Incidence of sensory hearing loss

Secondary Outcome Measures

Name	Time	Method
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
Invasive ventilatory support	Day 28	Incidence of invasive ventilatory support
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 Events	Day 28	Incidence of adverse events
Adverse outcomes requiring secondary intervention by etiology	Day 180	Incidence of adverse outcomes by etiology