Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 624
- 试验地点
- 6
- 主要终点
- Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Mortality
时间窗: Day 28
The primary outcome is the incidence of all-cause death
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
时间窗: 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
次要结局
- Re-hospitalization(Day 28)
- Length of hospital stay(Day 28)
- First dose of antibiotic therapy(Day 28)
- Sensory hearing loss(Day 28)
- Post-meningitis assistive devices(Day 180)
- Patients with guideline-directed therapy(Day 180)
- Mortality in six months(Day 180)
- Length of hospitalization by etiology(Day 180)
- Re-hospitalization rate(Day 180)
- Invasive ventilatory support(Day 28)
- Access to specialized rehabilitation services(Day 180)
- Re-hospitalization rate by etiology(Day 180)
- Neurological sequelae by etiology(Day 180)
- Post-discharge functional decline(Day 180)
- Adverse Events(Day 28)
- Adverse outcomes requiring secondary intervention by etiology(Day 180)