A Prospective, Multicenter, Double-blind, Randomized, Comparative Study to Estimate the Safety, Tolerability and Efficacy of NXL104/Ceftazidime Plus Metronidazole vs. Meropenem in the Treatment of Complicated Intra-abdominal Infections in Hospitalized Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 204
- 试验地点
- 45
- 主要终点
- Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
研究概览
简要总结
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complicated intra-abdominal infections
排除标准
- •infections limited to hollow viscus
- •ischemic bowel disease without perforation
- •acute suppurative cholangitis
- •acute necrotizing pancreatitis
- •pts to undergo stated abdominal repair, open abdomen technique or marsupialization
- •Apache II >25
研究组 & 干预措施
NXL104/CAZ/MTZ
NXL104/ceftazidime + metronidazole
干预措施: ceftazidime/NXL104 + metronidazole (Drug)
Meropenem
干预措施: meropenem (Drug)
结局指标
主要结局
Number of Participants With Clinical Response at the Test of Cure (TOC) Visit
时间窗: Test of cure visit: 2 weeks post-therapy (Day 28)
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 6 weeks after last dose of study treatment (up to a maximum of 8 weeks)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Number of Participants With Clinical Response at the End of Intravenous (IV) Therapy(End of IV therapy: From Day 5 to Day 14)
- Number of Participants With Clinical Response at the Late Follow-up Visit(Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks))
- Number of Participants With Microbiological Response at the Test of Cure Visit(Test of cure visit: 2 weeks post-therapy (Day 28))
- Number of Participants With Clinical Response in CE Participants at the End of IV Therapy(End of IV therapy: From Day 5 to Day 14)
- Number of Participants With Clinical Response in Clinically Evaluable (CE) Participants at the Test of Cure Visit(Test of cure visit: 2 weeks post-therapy (Day 28))
- Number of Participants With Microbiological Response at the End of IV Therapy(End of IV therapy: From Day 5 to Day 14)
- Number of Participants With Microbiological Response at the Late Follow-up Visit(Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks))
- Number of Participants With Clinical Response in CE Participants at the Late Follow-up Visit(Late follow-up visit: 4 to 6 weeks post-therapy (up to 8 weeks))