Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be enrolled. The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days. Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
详细描述
Objectives:
To determine effectiveness and safety of tigecycline for therapy of hospitalized patients with infections due to MDR A. baumannii.
Study Design Open label phase IV study
Sample Size:
It is estimated that a favorable response rate in patients infected with MDR A. baumannii who received tigecycline is 60% +/- 20% with 5% type I error. Therefore the estimated sample size is 24 patients. This study will enroll 30 patients in order to compensate for some patients who may not be available to have a complete follow up.
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
- •Hospitalized male or female aged 18 years or older
- •Has documented infection due to A. baumannii resistant to cephalosporins, beta-lactams/ beta-lactamase inhibitors, aminoglycosides, fluoroquinolones and carbapenems
- •Willing to join the study by signing a written informed consent form
排除标准
- •Pregnant or lactating woman
- •Has contraindication for receiving tigecycline such as allergy to tetracycline
- •Has received colistin for more than 24 hours
- •Unable to receive tigecycline monotherapy
研究组 & 干预措施
Tigecycline
Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
干预措施: Tigecycline (Drug)
结局指标
主要结局
Effectiveness
时间窗: at the end of therapy (up to 28 days)
Clinical response is classified as cure, improvement, failure, relapse, death.
次要结局
- Microbiological outcomes(At the end of therapy (up to 28 days))
研究者
Visanu Thamlikitkul
Faculty of Medicine Siriraj Hospital
Mahidol University