JPRN-UMIN000010144已完成未知
Study of the clinical efficacy and number of days of tebipenem pivoxil administration for the treatment of pediatric bacterial pneumonia. - Clinical efficacy of tebiepenem pivoxil for the treatment of childhood pneumonia.
Department of Pediatrics, Kawasaki Medical School0 个研究点目标入组 100 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 16years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Pediatric patients with other infectious foci who are potentially unresponsive to treatment with orally administered medication. 2) Pediatric patients in whom the efficacy and safety of the study drug is difficult to determine because of a progressive, complicated, or severe underlying disease believed to critically influence the onset of the infection, its clinical course, and therapeutic efficacy. 3) Pediatric patients with convulsive disorders, such as epilepsy, as an underlying disease. 4) Pediatric patients with a lipid metabolism disorder or congenital carnitine deficiency. 5) Pediatric patients with severe hepatic or renal dysfunction. To determine whether the pediatric patient is appropriate for this study, the attending physician must judge the child's condition on the basis of the following laboratory values: - Liver function values: AST (GOT) levels over 100 IU/L or ALT (GPT) levels over 100 IU/L. - Renal function values: BUN over 25 mg/dL or serum creatinine levels over 2.0 mg/dL. 6) Pediatric patients with poor oral ingestion or receiving parenteral feeding. 7) Pediatric patients with a history of allergy to beta-lactam antibiotics (e.g.,carbapenems, penicillin, and cephem). 8) Pediatric patients who have received other antibiotics and exhibited improvements. 9) Pediatric patients deemed inappropriate for this study by the attending physician.
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