Population Pharmacokinetics of Cephalosporins and Macrolides in Children With Community Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- maximum concentration (Cmax)
研究概览
简要总结
This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects.
Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols.
- •Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item:
- •With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain;
- •With pulmonary consolidation and crackles;
- •White blood cells>10×10^9/L or <4×10^9/L;
- •X-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion.
- •Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).
排除标准
- •It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
- •It does not agree to participate in this study.
结局指标
主要结局
maximum concentration (Cmax)
时间窗: up to 4 weeks
次要结局
- half-life (t1/2)(up to 4 weeks)
- time to achieve maximum concentration (Tmax)(up to 4 weeks)
- absorption rate constant (ka)(up to 4 weeks)
- elimination rate constant (kel)(up to 4 weeks)
研究者
Kunling Shen
Chief of China National Clinical Research Center for Respiratory Diseases
Beijing Children's Hospital