NCT03696303已完成不适用
Determination of the Utility of Pfizer's Pneumococcal Urine Antigen Test in Children 5 Years of Age or Younger With Community Acquired Pneumonia in Guatemala
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 959
- 试验地点
- 3
- 主要终点
- Urinary antigen detection cut-points for invasive S. pneumoniae disease
研究概览
简要总结
This prospective case-control study aims to evaluate the utility and establish laboratory thresholds for a multi-serotype urine antigen test for the diagnosis of pneumococcal community acquired pneumonia in children 5 years of age or younger in Guatemala.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 31 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age older than 1 month (31 days) and up to 71 months and 28 days.
- •Diagnosis of radiologically confirmed pneumonia per WHO criteria in the ED or hospital within 48 hours of hospital admission
- •Signed informed consent by parents or legal guardian to participate in the study
排除标准
- •Known immunodeficiency
- •Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
- •Significant neurological disorder
- •Hospitalization within the previous 30 days for pneumonia or respiratory infection
- •Use of parenteral antibiotics for current illness (leading to diagnosis of pneumonia)
- •Transferred to the study hospital after already being hospitalized at a different location for ≥ 48 hours
- •Inclusion Criteria:
- •Age 1 to 71 months and signed informed consent by parents or legal guardian
- •Exclusion Criteria:
- •Known immunodeficiency
- •Major congenital malformation (e.g., hemodynamically compromised congenital heart malformation or any malformation leading to recurrent pneumonia) or serious chronic disorder
- •Significant neurological disorder
- •Fever or suspicion of community-acquired pneumonia or other respiratory infectious disease (symptoms of cough, congestion, tachypnea, indrawing, etc.)
- •Hospitalization within the previous 30 days for pneumonia or respiratory infection
结局指标
主要结局
Urinary antigen detection cut-points for invasive S. pneumoniae disease
时间窗: Within 48 hours
To determine Cut-Points to discriminate a positive or negative urine antigen test that differentiates invasive disease versus the carriage state
次要结局
- Detection of S. pneumoniae serotypes using Urinary antigen detection assay(Within 48 hours)
研究者
研究点 (3)
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