Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
研究概览
简要总结
Prospective, multicenter, observational clinical registry of pediatric patients with acute infectious meningitis across approximately 20 public and private hospitals in Brazil. The study will include children under 18 years of age 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 will be performed at 28, 90 and 180 days after inclusion in the study.
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 (PNI), 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 (PCPC-BR and pediatric FSS - 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 pediatric 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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle.
排除标准
- •Refusal to provide consent for study participation
结局指标
主要结局
Mortality, re-hospitalization, length of hospital stay and sensory hearing loss
时间窗: Day 28
The primary outcome is a composite endpoint and for that a hierarchical statistical analysis of the components will be applied, considering their clinical importance and the temporal relevance between events (mortality will take precedence over the other components: incidence of all-cause re-hospitalization, length of initial hospital stay -measured in days and incidence of sensory hearing loss). The statistical methodology will include the use of the hierarchical Win Ratio and/or equivalent approaches.
次要结局
- Invasive ventilatory support(Day 28)
- Patients with guideline-directed therapy(Day 180)
- Mortality in six months(Day 180)
- Length of hospitalization by etiology(Day 180)
- Neurological sequelae by etiology(Day 180)
- Post-discharge functional neurological decline(Day 28 and day 180)
- Cerebral Performance Post-Meningitis(Day 28 and day 180)
- Adverse Events(Day 28)
- Adverse outcomes by etiology(Day 180)
- Rate of re-hospitalization(Day 180)
- Re-hospitalization rate by etiology(Day 180)
- Access to specialized rehabilitation services post-discharge(Day 28, day 90 and day 180)
- Adverse Events(Day 28)