NCT00398099已完成3 期
Clinical Evaluation for the Efficacy, Safety, Tolerability & Medical Resource Utilization of Invanz (Ertapenem Sodium) Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
研究概览
简要总结
To collect clinical response data with the use of ertapenem in approved indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 20 years of age or older
- •Patients did not receive any systemic antibiotic before enrollment, or patients with failed clinical response (no improvement on symptoms or laboratory data) through previous antibiotic treatment
- •Patients who required therapy prior to identification of cause of infection
排除标准
- •Patient has a concomitant infection that may interfere with the evaluation of the response to ertapenem
- •Patient has an apache ii >
- •Patient has an infection caused by pathogens resistant to ertapenem
- •Patients with known allergy to ertapenem or other drugs in the same carbapenem class, beta - lactams, lidocaine or local anesthetics of the amide type
- •The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
结局指标
主要结局
Signs and symptoms of infection on days 3, 4, 7 and 14 during treatment
次要结局
- Safety and Tolerability
研究者
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