A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA-101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 21
- 主要终点
- Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection
详细描述
This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.
Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 to 90 years of age, inclusive.
- •Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power field in spun urine)
- •Clinical signs and/or symptoms of cUTI, either of:
- •a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;
- •b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:
- •Frequency;
- •Suprapubic pain;
- •ii. At least one of the following complicating factors:
- •Male gender;
- •Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
- •Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
- •Urogenital surgery within 7 days preceding administration of the first dose of study drug;
- •Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.
- •Exclusion Criteria
- •Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
- •Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
- •Complete, permanent obstruction of the urinary tract
- •Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
- •Suspected or confirmed perinephric or intrarenal abscess
- •Suspected or confirmed prostatitis
- •Known ileal loop or vesico-ureteral reflux
- •Women who are pregnant or nursing
排除标准
- 未提供
研究组 & 干预措施
1
CXA-101
干预措施: CXA-101 (Drug)
2
Ceftazidime
干预措施: Ceftazidime (Drug)
结局指标
主要结局
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
时间窗: TOC; 6-9 days after last study drug administration
Microbiological response is eradication for each baseline pathogen
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
时间窗: TOC; 6-9 days after last study drug administration
Microbiological response is eradication for each baseline pathogen
次要结局
未报告次要终点