A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 271
- 主要终点
- The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment
研究概览
简要总结
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adult patients with a suspected or documented complicated urinary tract infection
- •Female patients must test negative for pregnancy and agree to use adequate birth control measures
- •Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy
排除标准
- •Patients with complete obstruction of any portion of the urinary tract
- •Patients with rapidly progressive or terminal illness
- •Renal transplant patients
研究组 & 干预措施
ertapenem sodium (MK0826)
ertapenem sodium
干预措施: ertapenem sodium (MK0826) (Drug)
结局指标
主要结局
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment
时间窗: Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days
Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.
Microbiological Response Assessment Profile
时间窗: 5 to 9 days post-therapy
The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
次要结局
- Clinical Response Assessment Profile(5 to 9 days post-therapy)