NCT00379951已完成3 期
A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Safety and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
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
- •Patient has a complicated urinary tract infection
- •Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture
- •Patient is indian and 18 years of age or greater.
排除标准
- •Patient had a kidney transplant
- •Patient had been given antibiotic therapy for condition
- •Patient had poor liver function
- •Patient has complete obstruction of urinary tract
- •Patient has history of serious allergy to antibiotics and multivitamins
- •Patient is pregnant
- •Patient not likely to respond to 10 to 14 days of antibiotic therapy
- •Patient not likely to survive 4 week study period
研究组 & 干预措施
1
Experimental
Arm 1: ertapenem sodium
干预措施: ertapenem sodium (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 14 Days
次要结局
- Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment(14 days after treatment)
研究者
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