A Phase 3, Randomized, Double-blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 530
- 试验地点
- 88
- 主要终点
- Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
研究概览
简要总结
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 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. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female ≥ 18 years of age
- •Provide a signed written informed consent prior to any study-specific procedures
- •Meet the clinical criteria for either cUTI or AP
- •Requires hospitalization to manage the cUTI or AP
- •Agrees to use effective methods of contraception
排除标准
- •Known or suspected disease that may confound the assessment of efficacy.
- •Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
- •Rapidly progressive illness such that the subject is unlikely to survive the study period.
- •Pregnant or breastfeeding women
- •History of a seizure disorder requiring current treatment
- •Creatinine clearance < 15 mL/min or on renal dialysis
- •Neutropenia or elevated liver enzymes
- •Hypersensitivity to beta-lactam antibiotics
- •Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject
研究组 & 干预措施
Cefepime-zidebactam (FEP-ZID)
干预措施: Cefepime-zidebactam (FEP-ZID) (Drug)
Meropenem
干预措施: Meropenem (Drug)
结局指标
主要结局
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.
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 resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) 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)
次要结局
- Percent of subjects with microbiological eradication at Test-of-Cure(End of Treatment Visit (Day 17 ± 2 days))
- Plasma Concentration of FEP-ZID(On Days 1 and 3 of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion)
- Percentage of subjects with overall success at End-of-Treatment(End of Treatment Visit (Day 7 - 10 ± 1 day))
- Percentage of subjects with clinical cure at End-of-Treatment(End of Treatment Visit (Day 7 - 10 ± 1 day))
- Percent of subjects with microbiological eradication at End-of-Treatment(End of Treatment Visit (Day 7 - 10 ± 1 day))
- Percentage of subjects with clinical cure at Test-of-Cure(End of Treatment Visit (Day 17 ± 2 days))
- Percentage of subjects with clinical cure at Late Follow-up(End of Treatment Visit (Day 26 ± 2 days))