A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 483
- 主要终点
- The clinical response measured at late follow-up visit.
研究概览
简要总结
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
详细描述
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.
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
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
- •Has a requirement for surgical intervention within 24 hours of study entry
- •Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections
排除标准
- •Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
- •Any rapidly-progressing disease or immediately life-threatening illness
结局指标
主要结局
The clinical response measured at late follow-up visit.
次要结局
- The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.