A Phase III, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-Tazobactam vs. Meropenem Followed by Optional Oral Therapy in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Wockhardt
- 入组人数
- 1,004
- 主要终点
- Percentage of subjects with overall success at Day 5
研究概览
简要总结
This is a Phase III, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-TAZ vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
详细描述
Approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria
Subjects will be randomized in a 1:1 ratio according to an Interactive Response Technology (IRT) electronic system to receive either FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV every eight hours (q8h) or meropenem 1 g IV q8h. FEP-TAZ will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)
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
- •Meet the following clinical criteria for either cUTI or AP:
- •Have at least TWO of the following new-onset or worsening symptoms or signs:
- •Fever (oral, tympanic, or rectal temperature >38°C [>100.4°F]), which must be observed and documented by a health care provider Nausea or vomiting Dysuria, increased urinary frequency, or urinary urgency Lower abdominal, suprapubic, or pelvic pain
- •Have at least ONE complicating factor
- •B. AP, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least ONE of the following new-onset or worsening symptoms or signs:
- •Evidence of pyuria within 48 h prior to randomization,
排除标准
- •Known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy.
- •Receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization
- •Rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period
研究组 & 干预措施
WCK 4282 (FEP-TAZ) 4 g
WCK 4282 (FEP-TAZ) Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
干预措施: WCK 4282 (FEP-TAZ) 4 g (Drug)
WCK 4282 (FEP-TAZ) 4 g
WCK 4282 (FEP-TAZ) Pharmaceutical dosage form: Intravenous infusion Dosage: 4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
干预措施: ciprofloxacin 500 mg Optional Oral Switch (Drug)
Meropenem
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
干预措施: Meropenem (Drug)
Meropenem
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
干预措施: ciprofloxacin 500 mg Optional Oral Switch (Drug)
Meropenem
Meropenem Pharmaceutical dosage form: Intravenous infusion Dosage: 1 g IV q8h, infused over 45 min
干预措施: Infusion of normal saline (Other)
结局指标
主要结局
Percentage of subjects with overall success at Day 5
时间窗: Day 5
Overall success is defined as complete resolution (or return to premorbid state) of the cUTI or AP symptoms that were present at screening, except flank pain (if present), which should show at least one grade improvement and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Percentage of subjects with overall success at Test-of-Cure
时间窗: Test Of Cure Visit (Day 17 ± 2 days)
Overall success is defined as complete resolution1 (or return to premorbid state) of the cUTI or AP symptoms that were present at Screening and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
时间窗: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)
Collection of number of adverse events.
次要结局
未报告次要终点