Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
NCT ID: NCT03840148
Last Updated: 2025-06-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
661 participants
INTERVENTIONAL
2019-08-07
2021-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
NCT04951505
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
NCT03687255
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
NCT03788967
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
NCT02166476
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
NCT07089186
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cefepime/VNRX-5133 (taniborbactam)
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
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.
Meropenem
Meropenem will be administered q8h IV over 30 minutes.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented diagnosis of pyuria
* Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Venatorx Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site 184003
Buena Park, California, United States
Site 184002
Chula Vista, California, United States
Site 184001
La Mesa, California, United States
184012
Northridge, California, United States
Site 103203
Córdoba, , Argentina
Site 107601
Belo Horizonte, , Brazil
Site 107608
São Paulo, , Brazil
Site 110009
Gabrovo, , Bulgaria
Site 110002
Pleven, , Bulgaria
Site 110007
Plovdiv, , Bulgaria
Site 110003
Rousse, , Bulgaria
Site 110010
Sofia, , Bulgaria
Site 110004
Sofia, , Bulgaria
Site 110005
Sofia, , Bulgaria
Site 110008
Sofia, , Bulgaria
Site 110001
Veliko Tarnovo, , Bulgaria
Site 156022
Baotou, , China
Site 156002
Beijing, , China
Site 156006
Beijing, , China
Site 156015
Chendu, , China
Site 156011
Chongqing, , China
Site 156012
Chongqing, , China
Site 156004
Dalian, , China
Site 156030
Fujian, , China
Site 156014
Guangdong, , China
Site 156027
Guangdong, , China
Site 156025
Guangzhou, , China
Site 156018
Guiyang, , China
Site 156003
Nanchang, , China
Site 156005
Nanjing, , China
Site 156008
Nanjing, , China
Site 156007
Nanjing, , China
Site 156013
Ningbo, , China
Site 156028
Shandong, , China
Site 156017
Shanghai, , China
Site 156016
Shijiazhuang, , China
Site 156020
Tianjin, , China
Site 156029
Ürümqi, , China
Site 156010
Xiamen, , China
Site 119103
Split, , Croatia
Site 119101
Zagreb, , Croatia
Site 119106
Zagreb, , Croatia
Site 134801
Budapest, , Hungary
Site 134803
Nyíregyháza, , Hungary
Site 134804
Szeged, , Hungary
Site 142803
Daugavpils, , Latvia
Site 142804
Riga, , Latvia
Site 142801
Riga, , Latvia
Site 148402
Colima, , Mexico
Site 148401
Guadalajara, , Mexico
Site 160403
Cuzco, , Peru
Site 160410
Lima, , Peru
Site 160406
Lima, , Peru
Site 160404
Trujillo, , Peru
Site 164206
Bucharest, , Romania
Site 164205
Bucharest, , Romania
Site 164204
Bucharest, , Romania
Site 164201
Craiova, , Romania
Site 164307
Moscow, , Russia
Site 164301
Penza, , Russia
Site 164308
Pyatigorsk, , Russia
Site 164311
Rostov-on-Don, , Russia
Site 164303
Saint Petersburg, , Russia
Site 164302
Saratov, , Russia
Site 189001
Belgrade, , Serbia
Site 189002
Belgrade, , Serbia
Site 179207
Adapazarı, , Turkey (Türkiye)
Site 179203
Bornova, , Turkey (Türkiye)
Site 179202
Bostancı, , Turkey (Türkiye)
Site 179205
Çankaya, , Turkey (Türkiye)
Site 179204
Diyarbakır, , Turkey (Türkiye)
Site 180404
Dnipro, , Ukraine
Site 180408
Ivano-Frankivsk, , Ukraine
Site 180402
Kharkiv, , Ukraine
Site 180406
Kyiv, , Ukraine
Site 180401
Lutsk, , Ukraine
Site 180403
Vinnytsia, , Ukraine
Site 180407
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Moeck G, Gasink LB, Mendes RE, Woosley LN, Dorr M, Chen H, Wagenlehner FM, Henkel T, McGovern PC. Patient outcomes by baseline pathogen resistance phenotype and genotype in CERTAIN-1, a Phase 3 study of cefepime-taniborbactam versus meropenem in adults with complicated urinary tract infection. Antimicrob Agents Chemother. 2024 Jul 9;68(7):e0023624. doi: 10.1128/aac.00236-24. Epub 2024 May 23.
Wagenlehner FM, Gasink LB, McGovern PC, Moeck G, McLeroth P, Dorr M, Dane A, Henkel T; CERTAIN-1 Study Team. Cefepime-Taniborbactam in Complicated Urinary Tract Infection. N Engl J Med. 2024 Feb 15;390(7):611-622. doi: 10.1056/NEJMoa2304748.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-001451-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VNRX-5133-201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.