Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections (CERTAIN-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Acute Pyelonephritis
• Intervention / Treatment: Drug: Cefepime/VNRX-5133 (taniborbactam); Drug: Meropenem

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5016KEH
    • Site 103203
• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Site 107601
  • San Paolo, Brazil, 04039-901
    • Site 107608
• Bulgaria
  • Gabrovo, Bulgaria, 5300
    • Site 110009
  • Pleven, Bulgaria, 5800
    • Site 110002
  • Plovdiv, Bulgaria, 4003
    • Site 110007
  • Ruse, Bulgaria, 7002
    • Site 110003
  • Sofia, Bulgaria, 1407
    • Site 110010
  • Sofia, Bulgaria, 1606
    • Site 110004
  • Sofia, Bulgaria, 1606
    • Site 110005
  • Sofia, Bulgaria, 1606
    • Site 110008
  • Veliko Tarnovo, Bulgaria, 5000
    • Site 110001
• China
  • Baotou, China, 014010
    • Site 156022
  • Beijing, China, 100034
    • Site 156002
  • Beijing, China, 100050
    • Site 156006
  • Chendu, China, 610041
    • Site 156015
  • Chongqing, China, 400016
    • Site 156011
  • Chongqing, China, 400038
    • Site 156012
  • Dalian, China, 116023
    • Site 156004
  • Fujian, China, 362202
    • Site 156030
  • Guangdong, China, 515041
    • Site 156014
  • Guangdong, China, 518035
    • Site 156027
  • Guangzhou, China, 510120
    • Site 156025
  • Guiyang, China, 550002
    • Site 156018
  • Nanchang, China, 330006
    • Site 156003
  • Nanjing, China, 156005
    • Site 156005
  • Nanjing, China, 210008
    • Site 156008
  • Nanjing, China, 210009
    • Site 156007
  • Ningbo, China, 315010
    • Site 156013
  • Shandong, China, 276000
    • Site 156028
  • Shanghai, China, 200025
    • Site 156017
  • Shijiazhuang, China, 050000
    • Site 156016
  • Tianjin, China, 300192
    • Site 156020
  • Xiamen, China, 361003
    • Site 156010
  • Ürümqi, China, 830054
    • Site 156029
• Croatia
  • Split, Croatia, 21000
    • Site 119103
  • Zagreb, Croatia, 10000
    • Site 119101
  • Zagreb, Croatia, 10000
    • Site 119106
• Hungary
  • Budapest, Hungary, 1204
    • Site 134801
  • Nyiregyhaza, Hungary, 4400
    • Site 134803
  • Szeged, Hungary, 6725
    • Site 134804
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Site 142803
  • Riga, Latvia, LV-1002
    • Site 142804
  • Riga, Latvia, LV-1038
    • Site 142801
• Mexico
  • Colima, Mexico, 28018
    • Site 148402
  • Guadalajara, Mexico, 44280
    • Site 148401
• Peru
  • Cuzco, Peru, 84
    • Site 160403
  • Lima, Peru, 29
    • Site 160410
  • Lima, Peru, 41
    • Site 160406
  • Trujillo, Peru, TRUJ 01
    • Site 160404
• Romania
  • Bucharest, Romania, 050653
    • Site 164204
  • Bucuresti, Romania, 010825
    • Site 164206
  • Bucuresti, Romania, 020125
    • Site 164205
  • Craiova, Romania, 200642
    • Site 164201
• Russian Federation
  • Moscow, Russian Federation, 117593
    • Site 164307
  • Penza, Russian Federation, 440026
    • Site 164301
  • Pyatigorsk, Russian Federation, 357500
    • Site 164308
  • Rostov-on-Don, Russian Federation, 344011
    • Site 164311
  • Sankt Peterburg, Russian Federation, 194044
    • Site 164303
  • Saratov, Russian Federation, 410054
    • Site 164302
• Serbia
  • Belgrade, Serbia, 11000
    • Site 189001
  • Belgrade, Serbia, 11080
    • Site 189002
• Turkey
  • Adapazarı, Turkey, 54100
    • Site 179207
  • Bornova, Turkey, 35040
    • Site 179203
  • Bostanci, Turkey, 61080
    • Site 179202
  • Diyarbakır, Turkey, 21280
    • Site 179204
  • Çankaya, Turkey, 06800
    • Site 179205
• Ukraine
  • Dnipro, Ukraine, 49005
    • Site 180404
  • Ivano-Frankivs'k, Ukraine, 76014
    • Site 180408
  • Kharkiv, Ukraine, 6111
    • Site 180402
  • Kyiv, Ukraine, 02125
    • Site 180406
  • Luts'k, Ukraine, 43000
    • Site 180401
  • Vinnytsia, Ukraine, 21018
    • Site 180403
  • Zaporizhzhya, Ukraine, 69600
    • Site 180407
• United States
  • California
    • Buena Park, California, United States, 90620
      • Site 184003
    • Chula Vista, California, United States, 91911
      • Site 184002
    • La Mesa, California, United States, 91942
      • Site 184001
    • Northridge, California, United States, 91324
      • 184012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cefepime/VNRX-5133 (taniborbactam); Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.	Drug: Cefepime/VNRX-5133 (taniborbactam); Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
Active Comparator: Meropenem; Meropenem will be administered q8h IV over 30 minutes.	Drug: Meropenem; Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population	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.	Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiologic Success at Test of Cure (TOC) in the microITT Population	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.	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	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.	Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population	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. Symptomatic 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.	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	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.	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	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.	Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Clinical Success at End of Treatment (EOT) in the microITT Population	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.	Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Composite Success at Late Follow Up (LFU) in the microITT Population	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.	Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Microbiological Success at Late Follow Up (LFU) in the microITT Population	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.	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	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.	Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population	The proportion of patients with clinical success based on investigator opinion at TOC.	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	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.	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	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.	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	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.	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	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.	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 microITT Population	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.	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	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.	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	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.	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 Late Follow Up (LFU) in the microITT Population	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.	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	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.	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	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.	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	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.	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	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. Symptomatic 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.	Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Microbiologic Success at Test of Cure (TOC) in the ME Population	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.	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	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. Symptomatic 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.	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	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.	Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population	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. Symptomatic 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.	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	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.	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	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. Symptomatic 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.	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	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.	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	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. Symptomatic 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.	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	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.	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	Symptomatic 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.	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	Symptomatic 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.	Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Clinical Success at Late Follow Up (LFU) in the CE Population	Symptomatic 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.	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 End of Treatment (EOT) in the CE Population	Symptomatic 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.	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 Test of Cure (TOC) in the CE Population	Symptomatic 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.	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 Late Follow Up (LFU) in the CE Population	Symptomatic 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.	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 microITT Population	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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 microITT Population	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens. The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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 ME Population	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	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	Per-pathogen eradication by baseline gram-negative pathogens (only pathogens identified 10 or more times are reported). The number analyzed corresponds to the number of specified pathogens. The number is the percent of the specified pathogen identified at baseline in each treatment group that had been eradicated.	Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Treatment-Emergent Adverse Events	Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment.	Study Days 1 to 35
Number of Patients With Serious Adverse Events	Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).	Study Days 1 to 35

Collaborators and Investigators

• Sponsor: Venatorx Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): December 14, 2021

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Anti-Infective Agents; Bacterial Infections; Cefepime; Meropenem; Complicated Urinary Tract Infections; β-Lactamase Inhibitors; VNRX-5133 (taniborbactam)
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Nephritis; Nephritis, Interstitial; Pyelitis; Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis; Anti-Bacterial Agents; Anti-Infective Agents; Meropenem; Cefepime
• Other Study ID Numbers: VNRX-5133-201; 2018-001451-13 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No