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临床试验/NCT03840148
NCT03840148已完成3 期

A Phase 3, Randomized, Double-blind, Active Controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis

Venatorx Pharmaceuticals, Inc.78 个研究点 分布在 9 个国家目标入组 661 人开始时间: 2019年8月7日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
661
试验地点
78
主要终点
Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

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
Double (Participant, 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

  • •Adult male and female
  • •Documented diagnosis of pyuria
  • •Documented diagnosis of cUTI or Acute Pyelonephritis (AP)

排除标准

  • •Receipt of effective antibacterial drug therapy for cUTI for more than 24 hours during the previous 72 hours prior to randomization
  • •A urine culture result is resistant to meropenem or a gram negative pathogen is not identified or more than 2 microorganisms are isolated or a confirmed fungal UTI is identified
  • •Required use of nonstudy systemic bacterial therapy
  • •Suspected or confirmed prostatitis or urinary tract symptoms attributable to sexually transmitted disease
  • •Patients with perinephric or renal abscess
  • •Patients with renal transplantation or receiving hemodialysis or peritoneal dialysis
  • •Abnormal labs

研究组 & 干预措施

Cefepime/VNRX-5133 (taniborbactam)

Experimental

Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.

干预措施: Cefepime/VNRX-5133 (taniborbactam) (Drug)

Meropenem

Active Comparator

Meropenem will be administered q8h IV over 30 minutes.

干预措施: Meropenem (Drug)

结局指标

主要结局

Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population

时间窗: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI.

次要结局

  • Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Microbiologic Success at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Clinical Success at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiological Success at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiological Success at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiologic Success at End of Treatment (EOT) in the ME Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Composite Success at Test of Cure (TOC) in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Microbiologic Success at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success at Late Follow Up (LFU) in the CE Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiologic Success at Test of Cure (TOC) in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Clinical Success at Test of Cure (TOC) in the CE Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))
  • Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population(Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23))
  • Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population(Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35))
  • Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population(Assessed within 24 hours after last IV dose (up to 15 days from start of treatment))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (78)

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