Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.
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
- 0 Days 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: postnatal age ≤ 72h;
- •Meets NICE guidelines for using antibiotics to treat EONS;
- •Azlocillin used as part of antimicrobial treatment;
- •Parental written consent.
排除标准
- •Expected survival time less than the treatment cycle;
- •Major congenital malformations;
- •Undergoing surgery within the first week of life;
- •Receiving other systemic trial drug therapy;
- •Other factors that the researcher considers unsuitable for inclusion.
结局指标
主要结局
Treatment failure
时间窗: 72 hours after ending initial antibiotic therapy
* requiring additional courses of antibiotic therapy within 72 hours after ending initial antibiotic therapy and/or * progression of the illness, necessitating a change of antibiotic and/or * blood culture isolate reported resistant to the antibiotic.
次要结局
- Treatment duration(Through study completion, an average of 3 days)
- Duration of hospitalization(In the first month of patients' life)
- White blood cell count(Through study completion, an average of 3 days)
- C-reactive protein(Through study completion, an average of 3 days)
- PD target(Through study completion, an average of 3 days)
- Procalcitonin(Through study completion, an average of 3 days)
- Death(In the first month of patients' life)
- Adverse events(Through study completion, an average of 3 days)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University