Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
研究概览
简要总结
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).
详细描述
The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.
排除标准
- •pregnant patients
- •allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.
研究组 & 干预措施
Clostridium difficile Patient
Open non-comparative trial
干预措施: Tigecycline (Drug)
结局指标
主要结局
Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
时间窗: day 3 of treatment
Stool levels of tigecycline
Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates
时间窗: day 1 stool sample
Mean (SD) Stool Tigecycline Concentration Level
时间窗: day 3 of tigecycline therapy
Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay
Mean (SD) Serum Tigecycline Concentration Level
时间窗: day 3 of tigecycline therapy
Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.
次要结局
未报告次要终点
研究者
Gary E. Stein, Pharm.D.
Professor of Medicine and Pharmacology
Michigan State University