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

NCT03840148 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: VNRX-5133-2012018-001451-13
• Study Type: interventional
• Target: 661
• Locations: 15 countries
• Sites: 78

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.

Conditions

Urinary Tract Infections; Acute Pyelonephritis

Keywords

Bacterial Infections; Cefepime; Meropenem; Complicated Urinary Tract Infections; Anti-Infective Agents; β-Lactamase Inhibitors; VNRX-5133 (taniborbactam)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (49)

• Microbiologic Success at Test of Cure (TOC) in the microITT Population

  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

  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

  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

  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

  Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)

Other Outcomes (2)

• Number of Patients With Treatment-Emergent Adverse Events

  Study Days 1 to 35

• Number of Patients With Serious Adverse Events

  Study Days 1 to 35

Study Arms (2)

Cefepime/VNRX-5133 (taniborbactam)

EXPERIMENTAL

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

Drug: Cefepime/VNRX-5133 (taniborbactam)

Meropenem

ACTIVE COMPARATOR

Meropenem will be administered q8h IV over 30 minutes.

Drug: Meropenem

Interventions

Cefepime/VNRX-5133 (taniborbactam) DRUG

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.

Cefepime/VNRX-5133 (taniborbactam)

Meropenem DRUG

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.

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Venatorx Pharmaceuticals, Inc.: lead

Study Sites (78)

Site 184003

Buena Park, California, 90620, United States

Location

Site 184002

Chula Vista, California, 91911, United States

Location

Site 184001

La Mesa, California, 91942, United States

Location

184012

Northridge, California, 91324, United States

Location

Site 103203

Córdoba, X5016KEH, Argentina

Location

Site 107601

Belo Horizonte, 30150-221, Brazil

Location

Site 107608

São Paulo, 04039-901, Brazil

Location

Site 110009

Gabrovo, 5300, Bulgaria

Location

Site 110002

Pleven, 5800, Bulgaria

Location

Site 110007

Plovdiv, 4003, Bulgaria

Location

Site 110003

Rousse, 7002, Bulgaria

Location

Site 110010

Sofia, 1407, Bulgaria

Location

Site 110004

Sofia, 1606, Bulgaria

Location

Site 110005

Sofia, 1606, Bulgaria

Location

Site 110008

Sofia, 1606, Bulgaria

Location

Site 110001

Veliko Tarnovo, 5000, Bulgaria

Location

Site 156022

Baotou, 014010, China

Location

Site 156002

Beijing, 100034, China

Location

Site 156006

Beijing, 100050, China

Location

Site 156015

Chendu, 610041, China

Location

Site 156011

Chongqing, 400016, China

Location

Site 156012

Chongqing, 400038, China

Location

Site 156004

Dalian, 116023, China

Location

Site 156030

Fujian, 362202, China

Location

Site 156014

Guangdong, 515041, China

Location

Site 156027

Guangdong, 518035, China

Location

Site 156025

Guangzhou, 510120, China

Location

Site 156018

Guiyang, 550002, China

Location

Site 156003

Nanchang, 330006, China

Location

Site 156005

Nanjing, 156005, China

Location

Site 156008

Nanjing, 210008, China

Location

Site 156007

Nanjing, 210009, China

Location

Site 156013

Ningbo, 315010, China

Location

Site 156028

Shandong, 276000, China

Location

Site 156017

Shanghai, 200025, China

Location

Site 156016

Shijiazhuang, 050000, China

Location

Site 156020

Tianjin, 300192, China

Location

Site 156029

Ürümqi, 830054, China

Location

Site 156010

Xiamen, 361003, China

Location

Site 119103

Split, 21000, Croatia

Location

Site 119101

Zagreb, 10000, Croatia

Location

Site 119106

Zagreb, 10000, Croatia

Location

Site 134801

Budapest, 1204, Hungary

Location

Site 134803

Nyíregyháza, 4400, Hungary

Location

Site 134804

Szeged, 6725, Hungary

Location

Site 142803

Daugavpils, LV-5417, Latvia

Location

Site 142804

Riga, LV-1002, Latvia

Location

Site 142801

Riga, LV-1038, Latvia

Location

Site 148402

Colima, 28018, Mexico

Location

Site 148401

Guadalajara, 44280, Mexico

Location

Site 160403

Cuzco, 84, Peru

Location

Site 160410

Lima, 29, Peru

Location

Site 160406

Lima, 41, Peru

Location

Site 160404

Trujillo, TRUJ 01, Peru

Location

Site 164206

Bucharest, 010825, Romania

Location

Site 164205

Bucharest, 020125, Romania

Location

Site 164204

Bucharest, 050653, Romania

Location

Site 164201

Craiova, 200642, Romania

Location

Site 164307

Moscow, 117593, Russia

Location

Site 164301

Penza, 440026, Russia

Location

Site 164308

Pyatigorsk, 357500, Russia

Location

Site 164311

Rostov-on-Don, 344011, Russia

Location

Site 164303

Saint Petersburg, 194044, Russia

Location

Site 164302

Saratov, 410054, Russia

Location

Site 189001

Belgrade, 11000, Serbia

Location

Site 189002

Belgrade, 11080, Serbia

Location

Site 179207

Adapazarı, 54100, Turkey (Türkiye)

Location

Site 179203

Bornova, 35040, Turkey (Türkiye)

Location

Site 179202

Bostancı, 61080, Turkey (Türkiye)

Location

Site 179205

Çankaya, 06800, Turkey (Türkiye)

Location

Site 179204

Diyarbakır, 21280, Turkey (Türkiye)

Location

Site 180404

Dnipro, 49005, Ukraine

Location

Site 180408

Ivano-Frankivsk, 76014, Ukraine

Location

Site 180402

Kharkiv, 6111, Ukraine

Location

Site 180406

Kyiv, 02125, Ukraine

Location

Site 180401

Lutsk, 43000, Ukraine

Location

Site 180403

Vinnytsia, 21018, Ukraine

Location

Site 180407

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 38780262 DERIVED

• 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.

  PMID: 38354140 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Bacterial Infections

Interventions

taniborbactam; Meropenem

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paul McGovern, MD
• Organization: Venatorx Pharmaceuticals, Inc.

mcgovern@venatorx.com

484-329-8615

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: August 7, 2019
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: June 6, 2025
• Results First Posted: May 29, 2024

Record last verified: 2025-06

Locations

AR (1); RU (6); CN (23); PE (4); US (4); ME (2); RO (4); SE (2); HU (3); UA (7); TU (5); BU (9); LA (3); CR (3); BR (2)