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

June 4, 2025 updated by: Venatorx Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
661

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population
Time Frame: 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.
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiologic Success at Test of Cure (TOC) in the microITT Population
Time Frame: 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.
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: 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. 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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: 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. 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
Time Frame: 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.
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: 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. 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
Time Frame: 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.
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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
Time Frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
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
Time Frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
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
Time Frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Treatment-Emergent Adverse Events
Time Frame: Study Days 1 to 35
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
Time Frame: Study Days 1 to 35
Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).
Study Days 1 to 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Venatorx Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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