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

Primary Purpose

Urinary Tract Infections, Acute Pyelonephritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cefepime/VNRX-5133 (taniborbactam)
Meropenem
Sponsored by
Venatorx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Bacterial Infections, Cefepime, Meropenem, Complicated Urinary Tract Infections, Anti-Infective Agents, β-Lactamase Inhibitors, VNRX-5133 (taniborbactam)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 184003
  • Site 184002
  • Site 184001
  • 184012
  • Site 103203
  • Site 107601
  • Site 107608
  • Site 110009
  • Site 110002
  • Site 110007
  • Site 110003
  • Site 110010
  • Site 110004
  • Site 110005
  • Site 110008
  • Site 110001
  • Site 156022
  • Site 156002
  • Site 156006
  • Site 156015
  • Site 156011
  • Site 156012
  • Site 156004
  • Site 156030
  • Site 156014
  • Site 156027
  • Site 156025
  • Site 156018
  • Site 156003
  • Site 156005
  • Site 156008
  • Site 156007
  • Site 156013
  • Site 156028
  • Site 156017
  • Site 156016
  • Site 156020
  • Site 156010
  • Site 156029
  • Site 119103
  • Site 119101
  • Site 119106
  • Site 134801
  • Site 134803
  • Site 134804
  • Site 142803
  • Site 142804
  • Site 142801
  • Site 148402
  • Site 148401
  • Site 160403
  • Site 160410
  • Site 160406
  • Site 160404
  • Site 164204
  • Site 164206
  • Site 164205
  • Site 164201
  • Site 164307
  • Site 164301
  • Site 164308
  • Site 164311
  • Site 164303
  • Site 164302
  • Site 189001
  • Site 189002
  • Site 179207
  • Site 179203
  • Site 179202
  • Site 179204
  • Site 179205
  • Site 180404
  • Site 180408
  • Site 180402
  • Site 180406
  • Site 180401
  • Site 180403
  • Site 180407

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefepime/VNRX-5133 (taniborbactam)

Meropenem

Arm Description

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

Meropenem will be administered q8h IV over 30 minutes.

Outcomes

Primary Outcome Measures

Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)
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.

Secondary Outcome Measures

Microbiological and symptomatic success at test of cure (TOC)
The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.
Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU)
The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.
Per-patient microbiological success at EOT, TOC and LFU
The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.
Patients with symptomatic clinical success at EOT, TOC and LFU
The proportion of patients with symptomatic clinical success at EOT, TOC and LFU.
Investigator opinion of clinical success at TOC
The proportion of patients with clinical success based on investigator opinion at TOC.
Per-pathogen microbiological success at EOT, TOC and LFU
The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.
Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU
The proportion of patients with both microbiological success and symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
The proportion of patients with per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
The proportion of patients with per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU.
Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens
The proportion of patients with symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU.

Full Information

First Posted
February 6, 2019
Last Updated
December 8, 2022
Sponsor
Venatorx Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03840148
Brief Title
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
Acronym
CERTAIN-1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venatorx Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Acute Pyelonephritis
Keywords
Bacterial Infections, Cefepime, Meropenem, Complicated Urinary Tract Infections, Anti-Infective Agents, β-Lactamase Inhibitors, VNRX-5133 (taniborbactam)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
661 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cefepime/VNRX-5133 (taniborbactam)
Arm Type
Experimental
Arm Description
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Arm Title
Meropenem
Arm Type
Active Comparator
Arm Description
Meropenem will be administered q8h IV over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
Cefepime/VNRX-5133 (taniborbactam)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of microbiological eradication and symptomatic clinical success in the microbiological intent-to-treat (microITT) population at test of cure (TOC)
Description
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.
Time Frame
Days 19-23
Secondary Outcome Measure Information:
Title
Microbiological and symptomatic success at test of cure (TOC)
Description
The proportion of patients with both microbiological success and symptomatic clinical success at TOC in the extended microITT population.
Time Frame
Days 19-23
Title
Clinical and microbiological success at end of treatment (EOT) and last follow-up (LFU)
Description
The proportion of patients with both microbiological success and symptomatic clinical success at EOT and LFU.
Time Frame
24 hours after last IV dose, Days 28-35
Title
Per-patient microbiological success at EOT, TOC and LFU
Description
The proportion of patients with per-patient microbiological success at EOT, TOC and LFU.
Time Frame
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Title
Patients with symptomatic clinical success at EOT, TOC and LFU
Description
The proportion of 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
Title
Investigator opinion of clinical success at TOC
Description
The proportion of patients with clinical success based on investigator opinion at TOC.
Time Frame
Days 19-23
Title
Per-pathogen microbiological success at EOT, TOC and LFU
Description
The proportion of patients with per-pathogen microbiological success at EOT, TOC and LFU.
Time Frame
Within 24 hours of last IV dose, Days 19-23, Days 28-35
Title
Microbiological and clinical success in cefepime-resistant pathogens at EOT, TOC and LFU
Description
The proportion of patients with both microbiological success and symptomatic clinical 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
Title
Per-patient microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
Description
The proportion of patients with 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
Title
Per-pathogen microbiological success among those with cefepime-resistant pathogens at EOT, TOC and LFU
Description
The proportion of patients with 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
Title
Symptomatic clinical success among those with cefepime-resistant pathogens at EOT, TOC and LFU cefepime-resistant pathogens
Description
The proportion of patients with symptomatic clinical 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
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Percent of participants experiencing adverse events.
Time Frame
Days 35
Title
Number of participants with serious adverse events
Description
Percent of participants experiencing serious adverse events.
Time Frame
Days 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Site 184003
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Site 184002
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Site 184001
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
184012
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Site 103203
City
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Site 107601
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Site 107608
City
San Paolo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Site 110009
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
Site 110002
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Site 110007
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Site 110003
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Site 110010
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Site 110004
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Site 110005
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Site 110008
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Site 110001
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Site 156022
City
Baotou
ZIP/Postal Code
014010
Country
China
Facility Name
Site 156002
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Site 156006
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Site 156015
City
Chendu
ZIP/Postal Code
610041
Country
China
Facility Name
Site 156011
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Site 156012
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Site 156004
City
Dalian
ZIP/Postal Code
116023
Country
China
Facility Name
Site 156030
City
Fujian
ZIP/Postal Code
362202
Country
China
Facility Name
Site 156014
City
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Site 156027
City
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Site 156025
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Site 156018
City
Guiyang
ZIP/Postal Code
550002
Country
China
Facility Name
Site 156003
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Site 156005
City
Nanjing
ZIP/Postal Code
156005
Country
China
Facility Name
Site 156008
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Site 156007
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Site 156013
City
Ningbo
ZIP/Postal Code
315010
Country
China
Facility Name
Site 156028
City
Shandong
ZIP/Postal Code
276000
Country
China
Facility Name
Site 156017
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Site 156016
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Site 156020
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Site 156010
City
Xiamen
ZIP/Postal Code
361003
Country
China
Facility Name
Site 156029
City
Ürümqi
ZIP/Postal Code
830054
Country
China
Facility Name
Site 119103
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Site 119101
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Site 119106
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Site 134801
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Site 134803
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Site 134804
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Site 142803
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Site 142804
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Site 142801
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Facility Name
Site 148402
City
Colima
ZIP/Postal Code
28018
Country
Mexico
Facility Name
Site 148401
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Site 160403
City
Cuzco
ZIP/Postal Code
84
Country
Peru
Facility Name
Site 160410
City
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Site 160406
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Site 160404
City
Trujillo
ZIP/Postal Code
TRUJ 01
Country
Peru
Facility Name
Site 164204
City
Bucharest
ZIP/Postal Code
050653
Country
Romania
Facility Name
Site 164206
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Site 164205
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Site 164201
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Site 164307
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Site 164301
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Site 164308
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Site 164311
City
Rostov-on-Don
ZIP/Postal Code
344011
Country
Russian Federation
Facility Name
Site 164303
City
Sankt Peterburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Site 164302
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Site 189001
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Site 189002
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Site 179207
City
Adapazarı
ZIP/Postal Code
54100
Country
Turkey
Facility Name
Site 179203
City
Bornova
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Site 179202
City
Bostanci
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Site 179204
City
Diyarbakır
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Site 179205
City
Çankaya
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Site 180404
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Site 180408
City
Ivano-Frankivs'k
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Site 180402
City
Kharkiv
ZIP/Postal Code
6111
Country
Ukraine
Facility Name
Site 180406
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Site 180401
City
Luts'k
ZIP/Postal Code
43000
Country
Ukraine
Facility Name
Site 180403
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Site 180407
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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