NCT00690378已完成2 期
Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 137
- 试验地点
- 58
- 主要终点
- Number of Participants With Microbiological Outcome 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 urinary tract 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
- Single (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
- •Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens
排除标准
- •ileal loops or vesicoureteral reflux
- •complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
- •fungal urinary tract infection
- •permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
- •history hypersensitivity to study medication
研究组 & 干预措施
1
Experimental
NXL/104 ceftazidime
干预措施: NXL104/ceftazidime (Drug)
2
Active Comparator
comparator 4 x daily
干预措施: Imipenem/Cilastatin (Drug)
结局指标
主要结局
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit
时间窗: 5 to 9 days post-therapy
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
次要结局
- Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit(4 to 6 weeks post-therapy)
- Clinical Outcome in CE Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit(4 to 6 weeks post-therapy)
- Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome in ME Patients at the LFU Visit(4 to 6 weeks post-therapy)
- Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit(4 to 6 weeks post-therapy)
- Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit(End of IV therapy (4 to 14 days))
- Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit(4 to 6 weeks post-therapy)
- Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit(5 to 9 days post-therapy)
- Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit(4 to 6 weeks post-therapy)
研究者
研究点 (58)
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