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

February 13, 2024 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

661

Phase

  • 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

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
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 of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)
Time Frame: Days 19-23
Microbiologic eradication is 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.
Days 19-23

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological and symptomatic success at test of cure (TOC)
Time Frame: Days 19-23
The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.
Days 19-23
Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU)
Time Frame: 24 hours after last IV dose, Days 28-35
The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.
24 hours after last IV dose, Days 28-35
Per-patient microbiological success at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Patients with symptomatic clinical success at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with symptomatic clinical success at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Investigator opinion of clinical success at TOC
Time Frame: Days 19-23
The proportion of patients with clinical success based on investigator opinion at TOC.
Days 19-23
Per-pathogen microbiological success at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with both microbiological success and symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens
Time Frame: Within 24 hours of last IV dose, Days 19-23, Days 28-35
The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Within 24 hours of last IV dose, Days 19-23, Days 28-35

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Days 35
Percent of participants experiencing adverse events.
Days 35
Number of participants with serious adverse events
Time Frame: Days 35
Percent of participants experiencing serious adverse events.
Days 35

Collaborators and Investigators

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

Sponsor

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)

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 (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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