Clinical trial NCT07027475: Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Official title: Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Viral Meningitis
Bacterial Meningitis
Fungal Meningitis
Meningitis
Keywords: Meningitis
Bacterial
Viral
Corticosteroids
Antibiotics
Fungal
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2025-06-18
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult, ≥ 18 years old, suspect acute meningitis infection

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
timeFrame: Day 28
Secondary outcomes:
measure: Patients with guideline-directed therapy
timeFrame: Day 180
measure: Mortality in six months
timeFrame: Day 180
measure: Length of hospitalization by etiology
timeFrame: Day 180
measure: Re-hospitalization rate
timeFrame: Day 180
measure: Invasive ventilatory support
timeFrame: Day 28
measure: Access to specialized rehabilitation services
timeFrame: Day 180
measure: Re-hospitalization rate by etiology
timeFrame: Day 180
measure: Neurological sequelae by etiology
timeFrame: Day 180
measure: Post-discharge functional decline
timeFrame: Day 180
measure: Adverse Events
timeFrame: Day 28
measure: Adverse outcomes requiring secondary intervention by etiology
timeFrame: Day 180
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Henrique A Fonseca, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein
name: Anna M Gomes, MD
role: PRINCIPAL_INVESTIGATOR
References: