A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
研究概览
简要总结
This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must meet the following inclusion criteria:
- •Have pyuria (white blood cells in the urine)
- •Clinical signs and/or symptoms of cUTI (including acute pyelonephritis)
- •Have a pretreatment baseline urine culture specimen
- •The subject's infection would require initial treatment with IV antibiotics
- •The subject must require initial hospitalization to manage the cUTI by the standard of care.
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins, carbapenems)
- •Confirmed fungal urinary tract infection
- •Intractable UTI anticipated to require more than 10 days of study drug therapy
- •Complete, permanent obstruction of the urinary tract\
- •Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter that will not be removed during IV study drug administration
- •Suspected or confirmed perinephric or intrarenal abscess
- •Suspected or confirmed prostatitis
- •Ileal loops or vesico-ureteral reflux
- •Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria
- •Renal transplantation
- •Life expectancy less than 3 months
- •Evidence of significant hepatic, hematological, or immunologic disease or dysfunction
- •Past or current history of epilepsy or seizure disorder
- •Women who are pregnant or nursing
研究组 & 干预措施
Ceftaroline fosamil and NXL104 (q8h)
干预措施: Ceftaroline fosamil and NXL104 (q8h) (Drug)
Ceftaroline fosamil and NXL104 (q8h)
干预措施: Placebo (Drug)
Ceftaroline fosamil and NXL104 (q12h)
干预措施: Ceftaroline fosamil and NXL104 (q12h) (Drug)
Ceftaroline fosamil and NXL104 (q12h)
干预措施: Placebo (Drug)
Doripenem
干预措施: Doripenem (Drug)
Doripenem
干预措施: Placebo (Drug)
结局指标
主要结局
Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
时间窗: 5 to 11 days after last dose of study drug
The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)
Evaluate safety
时间窗: from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug)
Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.
次要结局
- Clinical response in CE at Test of Cure(5 to 11 days after last dose of study drug)