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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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 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.
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality, re-hospitalization, length of hospital stay and sensory hearing loss | 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 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Patients with guideline-directed therapy | Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines | Day 180 |
| Mortality in six months |
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Inclusion Criteria:
Exclusion Criteria:
- Refusal to provide consent for study participation
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Adult, ≥ 18 years old, suspect acute meningitis infection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna M Gomes, MD | Contact | +55 11 2151-1233 | anna.gomes@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Henrique A Fonseca, MD, PhD | Hospital Israelita Albert Einstein | Study Chair |
| Anna M Gomes, MD | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Vicente de Paulo | Recruiting | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
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| ID | Term |
|---|---|
| D008587 | Meningitis, Viral |
| D016920 | Meningitis, Bacterial |
| D016921 | Meningitis, Fungal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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cerebrospinal fluid, blood (serum)
Incidence of all-cause mortality
| Day 180 |
| Length of hospitalization by etiology | Length of hospitalization (in days), stratified by infectious etiology | Day 180 |
| Re-hospitalization rate | Rate of all-cause re-hospitalization | Day 180 |
| Invasive ventilatory support | Incidence of invasive ventilatory support | Day 28 |
| Access to specialized rehabilitation services | Proportion of patients receiving specialized rehabilitation care | Day 180 |
| Re-hospitalization rate by etiology | Rate of unplanned re-hospitalization stratified by etiology | Day 180 |
| Neurological sequelae by etiology | Incidence of neurological sequelae stratified by etiology | 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:
| Day 180 |
| Adverse Events | Incidence of adverse events | Day 28 |
| Adverse outcomes requiring secondary intervention by etiology | Incidence of adverse outcomes by etiology | Day 180 |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP | Recruiting | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
|
| Hospital Santa Marcelina | Recruiting | São Paulo | São Paulo | 08270-070 | Brazil |
|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |