NCT00397956已完成3 期
An Open-Label, Single-Arm, Non-Comparative Study to Evaluate the Efficacy, Tolerability & Convenience of Invanz(TM) (Ertapenem Sodium) In the Treatment of Community-Acquired Sepsis in Adults
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 community acquired sepsis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 years of age or older
- •Patients present with at least two of the following signs and symptom:
- •fever (temperature> 38c or < 36c)
- •heart rate > 90 beats/min)
- •respiratory rate> 20 breaths/min)
- •high white blood cell count > 12,000/ul or >10% bands)
排除标准
- •Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem
- •Patient has a poor chance of survival for more than 14 days.
- •Patient has an apache ii score > 15 (see attachment
- •Patient has an infection caused by pathogens resistant to ertapenem
- •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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