Urinary Tract InfectionsPhase 3CERTAIN-1NCT03840148
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
A Phase 3 study testing Cefepime/VNRX-5133 (taniborbactam) and Meropenem in people with Urinary Tract Infections and Acute Pyelonephritis, run by Venatorx Pharmaceuticals, Inc. at 78 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Acute Pyelonephritis
- What is being tested?
- Cefepime/VNRX-5133 (taniborbactam) and Meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 78 sitesin 15 countries
- Study dates
- 7 Aug 2019to 14 Dec 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female
- Documented diagnosis of pyuria
- Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
Who cannot join
- 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
Trial locations and contacts
78 sites in 15 countries.
78 sites in 15 countries
China23 sites
Site 156022
Baotou, 014010
Site 156002
Beijing, 100034
Site 156006
Beijing, 100050
Site 156015
Chendu, 610041
Site 156011
Chongqing, 400016
Site 156012
Chongqing, 400038
Site 156004
Dalian, 116023
Site 156030
Fujian, 362202
Site 156014
Guangdong, 515041
Site 156027
Guangdong, 518035
Site 156025
Guangzhou, 510120
Site 156018
Guiyang, 550002
Site 156003
Nanchang, 330006
Site 156005
Nanjing, 156005
Site 156008
Nanjing, 210008
Site 156007
Nanjing, 210009
Site 156013
Ningbo, 315010
Site 156028
Shandong, 276000
Site 156017
Shanghai, 200025
Site 156016
Shijiazhuang, 050000
Site 156020
Tianjin, 300192
Site 156029
Ürümqi, 830054
Site 156010
Xiamen, 361003
Bulgaria9 sites
Site 110009
Gabrovo, 5300
Site 110002
Pleven, 5800
Site 110007
Plovdiv, 4003
Site 110003
Rousse, 7002
Site 110010
Sofia, 1407
Site 110004
Sofia, 1606
Site 110005
Sofia, 1606
Site 110008
Sofia, 1606
Site 110001
Veliko Tarnovo, 5000
Ukraine7 sites
Site 180404
Dnipro, 49005
Site 180408
Ivano-Frankivsk, 76014
Site 180402
Kharkiv, 6111
Site 180406
Kyiv, 02125
Site 180401
Lutsk, 43000
Site 180403
Vinnytsia, 21018
Site 180407
Zaporizhzhya, 69600
Russia6 sites
Site 164307
Moscow, 117593
Site 164301
Penza, 440026
Site 164308
Pyatigorsk, 357500
Site 164311
Rostov-on-Don, 344011
Site 164303
Saint Petersburg, 194044
Site 164302
Saratov, 410054
Turkey (Türkiye)5 sites
Site 179207
Adapazarı, 54100
Site 179203
Bornova, 35040
Site 179202
Bostancı, 61080
Site 179205
Çankaya, 06800
Site 179204
Diyarbakır, 21280
United States4 sites
Site 184003
Buena Park, California, 90620
Site 184002
Chula Vista, California, 91911
Site 184001
La Mesa, California, 91942
184012
Northridge, California, 91324
Peru4 sites
Site 160403
Cuzco, 84
Site 160410
Lima, 29
Site 160406
Lima, 41
Site 160404
Trujillo, TRUJ 01
Romania4 sites
Site 164206
Bucharest, 010825
Site 164205
Bucharest, 020125
Site 164204
Bucharest, 050653
Site 164201
Craiova, 200642
Croatia3 sites
Site 119103
Split, 21000
Site 119101
Zagreb, 10000
Site 119106
Zagreb, 10000
Hungary3 sites
Site 134801
Budapest, 1204
Site 134803
Nyíregyháza, 4400
Site 134804
Szeged, 6725
Latvia3 sites
Site 142803
Daugavpils, LV-5417
Site 142804
Riga, LV-1002
Site 142801
Riga, LV-1038
Brazil2 sites
Site 107601
Belo Horizonte, 30150-221
Site 107608
São Paulo, 04039-901
About this study
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
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
- Being tested
- Cefepime/VNRX-5133 (taniborbactam), Meropenem
- Keywords
- Bacterial Infections, Cefepime, Meropenem, Complicated Urinary Tract Infections, Anti-Infective Agents, β-Lactamase Inhibitors, VNRX-5133 (taniborbactam)
- Medical subject headings
- Urinary Tract Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MeropenemDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cefepime/VNRX-5133 (taniborbactam) | Experimental | Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period. Receives: Drug: Cefepime/VNRX-5133 (taniborbactam) |
| Meropenem | Active comparator | Meropenem will be administered q8h IV over 30 minutes. Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
The proportion of patients with clinical success based on investigator opinion at TOC.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start7 Aug 2019
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840148
- Sponsor's protocol ID
- VNRX-5133-201
- Other IDs
- 2018-001451-13, 2018
- Acronym
- CERTAIN-1
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2019
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Belley A, Cusick SM, Pevear DC, Koeth L, DiFranco-Fisher J, Kothari N, Hawser S, Moeck G. Establishing the reference broth microdilution MIC method for cefepime-taniborbactam. J Clin Microbiol. 2025 Sep 10;63(9):e0066125. doi: 10.1128/jcm.00661-25. Epub 2025 Aug 19.
PubMed 40827922Moeck 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.
PubMed 38780262Wagenlehner 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.
PubMed 38354140
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03840148
- Acronym / sponsor ID
- CERTAIN-1 / VNRX-5133-201
- Conditions
- Urinary Tract Infections, Acute Pyelonephritis
- Keywords
- Bacterial Infections, Cefepime, Meropenem, Complicated Urinary Tract Infections, Anti-Infective Agents, β-Lactamase Inhibitors, VNRX-5133 (taniborbactam)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- Venatorx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefepime/VNRX-5133 (taniborbactam) | Experimental | Drug: Cefepime/VNRX-5133 (taniborbactam)Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period. |
| Meropenem | Active comparator | Drug: MeropenemMeropenem will be administered q8h IV over 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male and female
- Documented diagnosis of pyuria
- Documented diagnosis of cUTI or Acute Pyelonephritis (AP)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Cefepime/VNRX-5133 (taniborbactam) |
| MeropenemMeropenem 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. | Drug | Meropenem |
Primary outcome
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.
49 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 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 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)
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 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 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)
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 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 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)
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 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)
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 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)
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 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)
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 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)
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 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)
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 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)
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)
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)
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)
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)
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)
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)
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 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 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40827922Belley A, Cusick SM, Pevear DC, Koeth L, DiFranco-Fisher J, Kothari N, Hawser S, Moeck G. Establishing the reference broth microdilution MIC method for cefepime-taniborbactam. J Clin Microbiol. 2025 Sep 10;63(9):e0066125. doi: 10.1128/jcm.00661-25. Epub 2025 Aug 19.
- Derived from this study: PubMed 38780262Moeck 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.
- Derived from this study: PubMed 38354140Wagenlehner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefepime/VNRX-5133 (taniborbactam) and Meropenem in people with Urinary Tract Infections and Acute Pyelonephritis, run by Venatorx Pharmaceuticals, Inc. at 78 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in China, Bulgaria, Ukraine, Russia, Turkey (Türkiye) and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03840148, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.