Acute Pyelonephritis, Urinary Tract Infections
Conditions
Keywords
Bacterial Infections, Cefepime, Meropenem, Complicated Urinary Tract Infections, Anti-Infective Agents, β-Lactamase Inhibitors, VNRX-5133 (taniborbactam)
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.
Interventions
DRUGCefepime/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.
DRUGMeropenem
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.
Sponsors
Venatorx Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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 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) | 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. |
| Composite Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Microbiological Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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 at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Investigator Opinion of 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) | The proportion of patients with clinical success based on investigator opinion at TOC. |
| Composite Success in Patients With Cefepime-Resistant Pathogens 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) | 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. |
| Microbiologic Success in Patients With Cefepime-Resistant Pathogens 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) | 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 in Patients With Cefepime-Resistant Pathogens 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) | 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. |
| Composite Success in Patients With Cefepime-Resistant Pathogens 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) | 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. |
| Microbiologic Success in Patients With Cefepime-Resistant Pathogens 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) | 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 in Patients With Cefepime-Resistant Pathogens 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 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. |
| Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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 in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Microbiologic Success at End of Treatment (EOT) in the ME Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Composite Success at Test of Cure (TOC) in the ME Population | 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. 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. |
| Microbiologic Success at Test of Cure (TOC) in the ME Population | 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. |
| Composite Success at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Microbiologic Success at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | 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. 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. |
| Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | 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. |
| Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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 at End of Treatment (EOT) in the Clinically Evaluable (CE) Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Clinical Success at Test of Cure (TOC) in the CE Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Clinical Success at Late Follow Up (LFU) in the CE Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Per-Pathogen Microbiologic Eradication 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) | 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. |
| Per-Pathogen Microbiologic Eradication 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) | 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. |
| Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens 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) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens 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) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | 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. |
| Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | 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. |
| Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Treatment-Emergent Adverse Events | Study Days 1 to 35 | Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment. |
| Number of Patients With Serious Adverse Events | Study Days 1 to 35 | Percent of participants experiencing treatment emergent Serious Adverse Events (SAE). |
Countries
Argentina, Brazil, Bulgaria, China, Croatia, Hungary, Latvia, Mexico, Peru, Romania, Russia, Serbia, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
Six-hundred sixty-one (661) male and female patients with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP), were randomized into 2 groups (cefepime - VNRX-5133, and meropenem) at 68 hospital sites in North and South America, Eastern Europe, and China, from August 2019 until the last patient's final visit in December 2021. Of these 661 patients in the intent-to-treat (ITT) population, 436 were in the MicroITT population (293 cefepime - VNRX-5133, 143 meropenem).
Pre-assignment details
Of the 697 patients screened, 36 patients did not qualify for randomization, and 661 patients were randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 441 |
| 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. | 220 |
| Total | 661 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study Completion Disposition | Covid-19 related | 2 | 0 |
| Study Completion Disposition | Death | 1 | 0 |
| Study Completion Disposition | IWRS issue, patient refused, SAE, randomized in error, patient did not take IMP or attend visits. | 3 | 3 |
| Study Completion Disposition | Lost to Follow-up | 1 | 1 |
| Study Completion Disposition | Physician Decision | 2 | 0 |
| Study Completion Disposition | Withdrawal by Subject | 6 | 2 |
| Study Drug Disposition | Adverse Event | 13 | 2 |
| Study Drug Disposition | Lack of Efficacy | 3 | 0 |
| Study Drug Disposition | Physician Decision | 2 | 0 |
| Study Drug Disposition | Randomized but not treated, IWRS issue, lack of IMP supplies. | 1 | 4 |
| Study Drug Disposition | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Total | Cefepime/VNRX-5133 (Taniborbactam) | Meropenem |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 17.66 | 56.2 years STANDARD_DEVIATION 17.43 | 55.8 years STANDARD_DEVIATION 18.15 |
| Age, Customized Age Categories (years) <65 | 412 Participants | 275 Participants | 137 Participants |
| Age, Customized Age Categories (years) 65 - 75 | 167 Participants | 111 Participants | 56 Participants |
| Age, Customized Age Categories (years) >75 | 82 Participants | 55 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants | 47 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 592 Participants | 393 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 36 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) White | 577 Participants | 386 Participants | 191 Participants |
| Sex: Female, Male Female | 363 Participants | 248 Participants | 115 Participants |
| Sex: Female, Male Male | 298 Participants | 193 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 440 | 0 / 217 |
| other Total, other adverse events | 93 / 440 | 37 / 217 |
| serious Total, serious adverse events | 9 / 440 | 4 / 217 |
Outcome results
Primary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | 207 Participants |
| Meropenem | Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | 83 Participants |
p-value: 0.008895% CI: [3.1, 22.2]Cochran-Mantel-Haenszel
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population | 384 Participants |
| Meropenem | Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population | 187 Participants |
95% CI: [-3.1, 7.3]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at End of Treatment (EOT) in the microITT Population | 265 Participants |
| Meropenem | Clinical Success at End of Treatment (EOT) in the microITT Population | 127 Participants |
95% CI: [-4.1, 8.5]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at Late Follow Up (LFU) in the CE Population | 321 Participants |
| Meropenem | Clinical Success at Late Follow Up (LFU) in the CE Population | 142 Participants |
95% CI: [1.2, 15.7]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at Late Follow Up (LFU) in the microITT Population | 238 Participants |
| Meropenem | Clinical Success at Late Follow Up (LFU) in the microITT Population | 102 Participants |
95% CI: [1.5, 18.8]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at Test of Cure (TOC) in the CE Population | 343 Participants |
| Meropenem | Clinical Success at Test of Cure (TOC) in the CE Population | 162 Participants |
95% CI: [-1.1, 11.5]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success at Test of Cure (TOC) in the microITT Population | 251 Participants |
| Meropenem | Clinical Success at Test of Cure (TOC) in the microITT Population | 116 Participants |
95% CI: [-2.6, 12.6]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population | Enterobacterales | 63 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population | Pseudomonas aeruginosa | 6 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population | Enterobacterales | 31 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population | Pseudomonas aeruginosa | 2 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Enterobacterales | 57 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Pseudomonas aeruginosa | 1 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Enterobacterales | 28 Participants |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population | Enterobacterales | 52 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population | Pseudomonas aeruginosa | 3 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population | Enterobacterales | 19 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population | Pseudomonas aeruginosa | 1 Participants |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Enterobacterales | 49 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Enterobacterales | 20 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The CE analysis population consists of all patients in the ITT analysis population who had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population | Enterobacterales | 56 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population | Pseudomonas aeruginosa | 4 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population | Enterobacterales | 23 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population | Pseudomonas aeruginosa | 2 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Enterbacterales | 54 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Enterbacterales | 25 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population | 259 Participants |
| Meropenem | Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population | 121 Participants |
95% CI: [-2.3, 10.5]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at End of Treatment (EOT) in the microITT Population | 261 Participants |
| Meropenem | Composite Success at End of Treatment (EOT) in the microITT Population | 123 Participants |
95% CI: [-3.2, 10.4]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at Late Follow Up (LFU) in the ME Population | 178 Participants |
| Meropenem | Composite Success at Late Follow Up (LFU) in the ME Population | 69 Participants |
95% CI: [3.8, 24.3]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at Late Follow Up (LFU) in the microITT Population | 187 Participants |
| Meropenem | Composite Success at Late Follow Up (LFU) in the microITT Population | 74 Participants |
95% CI: [2.2, 21.9]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The extended microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which at least 1 study drug (cefepime/VNRX-5133 and/or meropenem) have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | 216 Participants |
| Meropenem | Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | 86 Participants |
95% CI: [3, 21.8]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success at Test of Cure (TOC) in the ME Population | 195 Participants |
| Meropenem | Composite Success at Test of Cure (TOC) in the ME Population | 76 Participants |
95% CI: [5, 24.9]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Enterobacterales | 44 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Enterobacterales | 11 Participants |
95% CI: [3.8, 24.3]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Enterobacterales | 57 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 1 Participants |
| Meropenem | Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Enterobacterales | 26 Participants |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Enterobacterales | 45 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Enterobacterales | 13 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Enterobacterales | 44 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Enterobacterales | 12 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Enterobacterales | 47 Participants |
| Meropenem | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Enterobacterales | 16 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Enterobacterales | 56 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 1 Participants |
| Meropenem | Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Enterobacterales | 26 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population | 271 Participants |
| Meropenem | Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population | 128 Participants |
95% CI: [-2.4, 9.6]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiological Success at End of Treatment (EOT) in the microITT Population | 284 Participants |
| Meropenem | Microbiological Success at End of Treatment (EOT) in the microITT Population | 139 Participants |
95% CI: [-3.5, 4.1]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiological Success at Late Follow Up (LFU) in the microITT Population | 207 Participants |
| Meropenem | Microbiological Success at Late Follow Up (LFU) in the microITT Population | 90 Participants |
95% CI: [-1.6, 17.3]
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success at End of Treatment (EOT) in the ME Population | 279 Participants |
| Meropenem | Microbiologic Success at End of Treatment (EOT) in the ME Population | 137 Participants |
95% CI: [-3.1, 1.7]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success at Late Follow Up (LFU) in the ME Population | 192 Participants |
| Meropenem | Microbiologic Success at Late Follow Up (LFU) in the ME Population | 84 Participants |
95% CI: [-1.9, 17.7]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success at Test of Cure (TOC) in the ME Population | 214 Participants |
| Meropenem | Microbiologic Success at Test of Cure (TOC) in the ME Population | 88 Participants |
95% CI: [3.7, 22.3]
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success at Test of Cure (TOC) in the microITT Population | 229 Participants |
| Meropenem | Microbiologic Success at Test of Cure (TOC) in the microITT Population | 95 Participants |
95% CI: [2.9, 21]
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Enterobacterales | 45 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Cefepime-resistant Enterobacterales | 14 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Enterobacterales | 65 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 1 Participants |
| Meropenem | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Cefepime-resistant Enterobacterales | 28 Participants |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Enterobacterales | 48 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Cefepime-resistant Enterobacterales | 16 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Enterobacterales | 46 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population | Cefepime-resistant Enterobacterales | 14 Participants |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Enterobacterales | 50 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Pseudomonas aeruginosa | 0 Participants |
| Meropenem | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Cefepime-resistant Enterobacterales | 18 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Enterobacterales | 62 Participants |
| Cefepime/VNRX-5133 (Taniborbactam) | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Pseudomonas aeruginosa | 1 Participants |
| Meropenem | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population | Cefepime-resistant Enterobacterales | 28 Participants |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Citrobacter freundii complex | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella aerogenes | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella oxytoca | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella pneumoniae | 37 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella variicola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Proteus hauseri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Proteus mirabilis | 9 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Proteus vulgaris | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Serratia marcescens | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Pseudomonas aeruginosa | 11 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Citrobacter koseri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Enterobacter cloacae complex | 14 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Escherichia coli | 193 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella pneumoniae | 20 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Providencia rettgeri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Enterobacter cloacae complex | 3 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella variicola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Escherichia coli | 94 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Pseudomonas aeruginosa | 6 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella aerogenes | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Proteus mirabilis | 9 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population | Morganella morganii | 2 pathogens |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Citrobacter koseri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella oxytoca | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella pneumoniae | 37 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Proteus hauseri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Proteus mirabilis | 10 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Proteus vulgaris | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Serratia marcescens | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Pseudomonas aeruginosa | 11 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella variicola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Citrobacter freundii complex | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Enterobacter cloacae complex | 14 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Escherichia coli | 197 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella aerogenes | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Morganella morganii | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Enterobacter cloacae complex | 3 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Escherichia coli | 95 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Providencia rettgeri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella aerogenes | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Proteus mirabilis | 10 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella variicola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Klebsiella pneumoniae | 20 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population | Pseudomonas aeruginosa | 6 pathogens |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Citrobacter freundii complex | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella aerogenes | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella oxytoca | 3 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella pneumoniae | 29 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella variicola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Proteus hauseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Proteus mirabilis | 6 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Proteus vulgaris | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Serratia marcescens | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Pseudomonas aeruginosa | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Enterobacter cloacae complex | 12 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Escherichia coli | 130 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Providencia rettgeri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Enterobacter cloacae complex | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella variicola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Escherichia coli | 56 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Pseudomonas aeruginosa | 4 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella aerogenes | 0 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Proteus mirabilis | 6 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Morganella morganii | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population | Klebsiella pneumoniae | 14 pathogens |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Proteus mirabilis | 8 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella aerogenes | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella oxytoca | 4 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella pneumoniae | 30 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella variicola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Proteus vulgaris | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Serratia marcescens | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Pseudomonas aeruginosa | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Proteus hauseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Citrobacter freundii complex | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Citrobacter koseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Enterobacter cloacae complex | 12 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Escherichia coli | 141 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella pneumoniae | 14 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Pseudomonas aeruginosa | 4 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Enterobacter cloacae complex | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella variicola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Escherichia coli | 61 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Morganella morganii | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella aerogenes | 0 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Providencia rettgeri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population | Proteus mirabilis | 6 pathogens |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella pneumoniae | 26 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella aerogenes | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella oxytoca | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella variicola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Proteus hauseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Proteus mirabilis | 8 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Proteus vulgaris | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Serratia marcescens | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Pseudomonas aeruginosa | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Citrobacter freundii complex | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Citrobacter koseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Enterobacter cloacae complex | 11 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Escherichia coli | 154 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella variicola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Proteus mirabilis | 5 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Enterobacter cloacae complex | 0 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Pseudomonas aeruginosa | 4 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Escherichia coli | 64 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Morganella morganii | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella aerogenes | 0 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Klebsiella pneumoniae | 12 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population | Providencia rettgeri | 1 pathogens |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Citrobacter freundii complex | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella aerogenes | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella oxytoca | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella pneumoniae | 27 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella varricola | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Kluyvera ascorbata | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Morganella morganii | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Proteus hauseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Proteus mirabilis | 9 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Proteus penneri | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Proteus vulgaris | 1 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Serratia marcescens | 2 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Pseudomonas aeruginosa | 5 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Citrobacter koseri | 0 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Enterobacter cloacae complex | 12 pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Escherichia coli | 165 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Citrobacter freundii complex | 2 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella pneumoniae | 14 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Citrobacter koseri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Providencia rettgeri | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Enterobacter cloacae complex | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella varricola | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Escherichia coli | 67 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Pseudomonas aeruginosa | 4 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella aerogenes | 0 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Proteus mirabilis | 5 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Klebsiella oxytoca | 1 pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population | Morganella morganii | 2 pathogens |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at EOT with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Pseudomonas aeruginosa | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Escherichia coli | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Klebsiella pneumoniae | 95.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Proteus mirabilis | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Proteus mirabilis | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Klebsiella pneumoniae | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Escherichia coli | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the ME Population | Morganella morganii | 100 percentage of pathogen eradication |
Secondary
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.
Time frame: Assessed within 24 hours after last IV dose (up to 15 days from start of treatment)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Pseudomonas aeruginosa | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Escherichia coli | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Klebsiella pneumoniae | 95.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Proteus mirabilis | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Klebsiella pneumoniae | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Escherichia coli | 88.9 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Morganella morganii | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Proteus mirabilis | 100 percentage of pathogen eradication |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at LFU with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Pseudomonas aeruginosa | 0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Escherichia coli | 78.1 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Klebsiella pneumoniae | 68.4 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Proteus mirabilis | 50.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Enterobacter cloacae complex | 50.0 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Klebsiella pneumoniae | 71.4 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Escherichia coli | 53.3 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population | Proteus mirabilis | 0 percentage of pathogen eradication |
Secondary
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.
Time frame: Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Pseudomonas aeruginosa | 0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Escherichia coli | 73.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Klebsiella pneumoniae | 65.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Proteus mirabilis | 50.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Enterobacter cloacae complex | 50.0 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Klebsiella pneumoniae | 71.4 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Escherichia coli | 50.0 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Morganella morganii | 100 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Proteus mirabilis | 0 percentage of pathogen eradication |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: All patients who meet the criteria for the microITT population AND had a diagnosis of cUTI; received treatment for ≥48 hours; were evaluated at TOC with a response that was not indeterminate; did not violate prior antibacterials exclusion or received concomitant antibiotic therapy with activity against baseline pathogens except for patients failing study drug; or had other confounding factors that interfered with the assessment of outcome including unblinding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Pseudomonas aeruginosa | 0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Klebsiella oxytoca | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Klebsiella pneumoniae | 64.7 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Proteus mirabilis | 50.0 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Enterobacter cloacae complex | 100 percentage of pathogen eradication |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Escherichia coli | 87.5 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Enterobacter cloacae complex | 0 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Proteus mirabilis | 0 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Escherichia coli | 66.7 percentage of pathogen eradication |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure TOC in the ME Population | Klebsiella pneumoniae | 66.7 percentage of pathogen eradication |
Secondary
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.
Time frame: Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
Population: The microITT analysis population consists of all patients in the ITT analysis population who had a positive study entry urine culture defined as ≥10\^5 CFU/mL of a gram-negative pathogen(s) against which both cefepime/VNRX-5133 and meropenem have antibacterial activity AND those patients who had no more than 2 microorganisms identified in the study entry culture regardless of colony count.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Pseudomonas aeruginosa | 0 percentage of eradicated pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Escherichia coli | 81.1 percentage of eradicated pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Klebsiella oxytoca | 100 percentage of eradicated pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Klebsiella pneumoniae | 60.0 percentage of eradicated pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Proteus mirabilis | 50.0 percentage of eradicated pathogens |
| Cefepime/VNRX-5133 (Taniborbactam) | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Enterobacter cloacae complex | 100 percentage of eradicated pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Enterobacter cloacae complex | 50.0 percentage of eradicated pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Klebsiella pneumoniae | 71.4 percentage of eradicated pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Escherichia coli | 61.1 percentage of eradicated pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Morganella morganii | 100 percentage of eradicated pathogens |
| Meropenem | Per-Pathogen Microbiologic Eradication in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Proteus mirabilis | 0 percentage of eradicated pathogens |
Other Pre-specified
Number of Patients With Serious Adverse Events
Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).
Time frame: Study Days 1 to 35
Population: Patients with at least one treatment-emergent SAE.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Number of Patients With Serious Adverse Events | 9 Participants |
| Meropenem | Number of Patients With Serious Adverse Events | 4 Participants |
Other Pre-specified
Number of Patients With Treatment-Emergent Adverse Events
Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment.
Time frame: Study Days 1 to 35
Population: Patients with at least one TEAE.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/VNRX-5133 (Taniborbactam) | Number of Patients With Treatment-Emergent Adverse Events | 156 Participants |
| Meropenem | Number of Patients With Treatment-Emergent Adverse Events | 63 Participants |