Trial Outcomes & Findings for Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections (NCT NCT03840148)
NCT ID: NCT03840148
Last Updated: 2025-06-06
Results Overview
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.
COMPLETED
PHASE3
661 participants
Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23)
2025-06-06
Participant Flow
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).
Of the 697 patients screened, 36 patients did not qualify for randomization, and 661 patients were randomized into the trial.
Participant milestones
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
Meropenem will be administered q8h IV over 30 minutes.
Meropenem: Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
|
|---|---|---|
|
Study Drug Disposition
STARTED
|
441
|
220
|
|
Study Drug Disposition
COMPLETED
|
414
|
212
|
|
Study Drug Disposition
NOT COMPLETED
|
27
|
8
|
|
Study Completion Disposition
STARTED
|
441
|
220
|
|
Study Completion Disposition
COMPLETED
|
426
|
214
|
|
Study Completion Disposition
NOT COMPLETED
|
15
|
6
|
Reasons for withdrawal
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
Meropenem will be administered q8h IV over 30 minutes.
Meropenem: Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
|
|---|---|---|
|
Study Drug Disposition
Adverse Event
|
13
|
2
|
|
Study Drug Disposition
Withdrawal by Subject
|
8
|
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 Completion Disposition
Withdrawal by Subject
|
6
|
2
|
|
Study Completion Disposition
Physician Decision
|
2
|
0
|
|
Study Completion Disposition
Covid-19 related
|
2
|
0
|
|
Study Completion Disposition
Lost to Follow-up
|
1
|
1
|
|
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
|
Baseline Characteristics
Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=441 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=220 Participants
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.
|
Total
n=661 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 17.43 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 18.15 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 17.66 • n=5 Participants
|
|
Age, Customized
Age Categories (years) · <65
|
275 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Age, Customized
Age Categories (years) · 65 - 75
|
111 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Age, Customized
Age Categories (years) · >75
|
55 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
393 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
592 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
386 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
577 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population
|
207 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Microbiologic Success at Test of Cure (TOC) in the microITT Population
|
229 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Clinical Success at Test of Cure (TOC) in the microITT Population
|
251 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=305 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=147 Participants
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.
|
|---|---|---|
|
Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population
|
216 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Composite Success at End of Treatment (EOT) in the microITT Population
|
261 Participants
|
123 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Microbiological Success at End of Treatment (EOT) in the microITT Population
|
284 Participants
|
139 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Clinical Success at End of Treatment (EOT) in the microITT Population
|
265 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Composite Success at Late Follow Up (LFU) in the microITT Population
|
187 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Microbiological Success at Late Follow Up (LFU) in the microITT Population
|
207 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Clinical Success at Late Follow Up (LFU) in the microITT Population
|
238 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: 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.
The proportion of patients with clinical success based on investigator opinion at TOC.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=293 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=143 Participants
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.
|
|---|---|---|
|
Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population
|
271 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Cefepime-resistant Enterobacterales
|
57 Participants
|
26 Participants
|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Cefepime-resistant Enterobacterales
|
65 Participants
|
28 Participants
|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Enterobacterales
|
57 Participants
|
28 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population
Pseudomonas aeruginosa
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Cefepime-resistant Enterobacterales
|
47 Participants
|
16 Participants
|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Cefepime-resistant Enterobacterales
|
50 Participants
|
18 Participants
|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Enterbacterales
|
54 Participants
|
25 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population
Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Cefepime-resistant Enterobacterales
|
45 Participants
|
13 Participants
|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Cefepime-resistant Enterobacterales
|
48 Participants
|
16 Participants
|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Enterobacterales
|
49 Participants
|
20 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population
Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=282 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=137 Participants
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.
|
|---|---|---|
|
Composite Success at End of Treatment (EOT) in the Microbiologically-Evaluable (ME) Population
|
259 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=282 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=137 Participants
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.
|
|---|---|---|
|
Microbiologic Success at End of Treatment (EOT) in the ME Population
|
279 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=261 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=127 Participants
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.
|
|---|---|---|
|
Composite Success at Test of Cure (TOC) in the ME Population
|
195 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=261 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=127 Participants
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.
|
|---|---|---|
|
Microbiologic Success at Test of Cure (TOC) in the ME Population
|
214 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=262 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=128 Participants
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.
|
|---|---|---|
|
Composite Success at Late Follow Up (LFU) in the ME Population
|
178 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=262 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=128 Participants
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.
|
|---|---|---|
|
Microbiologic Success at Late Follow Up (LFU) in the ME Population
|
192 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=64 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=28 Participants
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.
|
|---|---|---|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population
Cefepime-resistant Enterobacterales
|
56 Participants
|
26 Participants
|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=64 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=28 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population
Cefepime-resistant Enterobacterales
|
62 Participants
|
28 Participants
|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at the End of Treatment (EOT) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=58 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=24 Participants
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.
|
|---|---|---|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population
Cefepime-resistant Enterobacterales
|
44 Participants
|
12 Participants
|
|
Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=58 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=24 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population
Cefepime-resistant Enterobacterales
|
46 Participants
|
14 Participants
|
|
Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=60 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=26 Participants
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.
|
|---|---|---|
|
Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population
Cefepime-resistant Enterobacterales
|
44 Participants
|
11 Participants
|
|
Composite Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=60 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=26 Participants
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.
|
|---|---|---|
|
Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population
Cefepime-resistant Enterobacterales
|
45 Participants
|
14 Participants
|
|
Microbiologic Success in Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the ME Population
Cefepime-resistant Pseudomonas aeruginosa
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=425 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=211 Participants
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.
|
|---|---|---|
|
Clinical Success at End of Treatment (EOT) in the Clinically Evaluable (CE) Population
|
384 Participants
|
187 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=392 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=196 Participants
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.
|
|---|---|---|
|
Clinical Success at Test of Cure (TOC) in the CE Population
|
343 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=387 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=190 Participants
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.
|
|---|---|---|
|
Clinical Success at Late Follow Up (LFU) in the CE Population
|
321 Participants
|
142 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=76 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=35 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population
Enterobacterales
|
63 Participants
|
31 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the CE Population
Pseudomonas aeruginosa
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=70 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population
Enterobacterales
|
56 Participants
|
23 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the CE Population
Pseudomonas aeruginosa
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=70 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Participants
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.
|
|---|---|---|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population
Enterobacterales
|
52 Participants
|
19 Participants
|
|
Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the CE Population
Pseudomonas aeruginosa
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=297 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=147 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Citrobacter koseri
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Enterobacter cloacae complex
|
14 pathogens
|
3 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Pseudomonas aeruginosa
|
11 pathogens
|
6 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Citrobacter freundii complex
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Escherichia coli
|
197 pathogens
|
95 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Klebsiella aerogenes
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Klebsiella oxytoca
|
5 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Klebsiella pneumoniae
|
37 pathogens
|
20 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Klebsiella variicola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Morganella morganii
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Proteus hauseri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Proteus mirabilis
|
10 pathogens
|
10 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Proteus vulgaris
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the microITT Population
Serratia marcescens
|
2 pathogens
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=297 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=147 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Citrobacter freundii complex
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Citrobacter koseri
|
0 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Enterobacter cloacae complex
|
12 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Escherichia coli
|
165 pathogens
|
67 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Klebsiella aerogenes
|
0 pathogens
|
0 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Klebsiella oxytoca
|
5 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Klebsiella pneumoniae
|
27 pathogens
|
14 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Klebsiella varricola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Morganella morganii
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Proteus hauseri
|
0 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Proteus mirabilis
|
9 pathogens
|
5 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Proteus vulgaris
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Serratia marcescens
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the microITT Population
Pseudomonas aeruginosa
|
5 pathogens
|
4 pathogens
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=297 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=147 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Enterobacter cloacae complex
|
12 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Escherichia coli
|
141 pathogens
|
61 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Klebsiella aerogenes
|
0 pathogens
|
0 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Klebsiella oxytoca
|
4 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Morganella morganii
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Proteus hauseri
|
0 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Pseudomonas aeruginosa
|
5 pathogens
|
4 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Citrobacter koseri
|
0 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Klebsiella pneumoniae
|
30 pathogens
|
14 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Klebsiella variicola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Proteus mirabilis
|
8 pathogens
|
6 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Proteus vulgaris
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Serratia marcescens
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the microITT Population
Citrobacter freundii complex
|
1 pathogens
|
2 pathogens
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 Pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 Pathogens
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.
|
|---|---|---|
|
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
|
88.9 percentage of pathogen eradication
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
—
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 pathogens
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.
|
|---|---|---|
|
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
|
50.0 percentage of eradicated pathogens
|
|
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
|
61.1 percentage of eradicated pathogens
|
|
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
|
—
|
|
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
|
71.4 percentage of eradicated pathogens
|
|
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
|
|
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
|
0 percentage of eradicated pathogens
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=67 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=30 pathogens
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.
|
|---|---|---|
|
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
|
50.0 percentage of pathogen eradication
|
|
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
|
50.0 percentage of pathogen eradication
|
|
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
|
—
|
|
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
|
71.4 percentage of pathogen eradication
|
|
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
|
|
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
|
0 percentage of pathogen eradication
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=286 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=141 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Citrobacter freundii complex
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Citrobacter koseri
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Enterobacter cloacae complex
|
14 pathogens
|
3 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Escherichia coli
|
193 pathogens
|
94 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Klebsiella aerogenes
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Klebsiella oxytoca
|
5 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Klebsiella pneumoniae
|
37 pathogens
|
20 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Klebsiella variicola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Morganella morganii
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Proteus hauseri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Proteus mirabilis
|
9 pathogens
|
9 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Proteus vulgaris
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Serratia marcescens
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at End of Treatment (EOT) in the ME Population
Pseudomonas aeruginosa
|
11 pathogens
|
6 pathogens
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=265 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=131 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Citrobacter freundii complex
|
2 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Citrobacter koseri
|
0 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Enterobacter cloacae complex
|
11 pathogens
|
0 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Escherichia coli
|
154 pathogens
|
64 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Klebsiella aerogenes
|
0 pathogens
|
0 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Klebsiella oxytoca
|
5 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Klebsiella pneumoniae
|
26 pathogens
|
12 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Klebsiella variicola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Morganella morganii
|
2 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Proteus hauseri
|
0 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Proteus mirabilis
|
8 pathogens
|
5 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Proteus vulgaris
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Serratia marcescens
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Test of Cure (TOC) in the ME Population
Pseudomonas aeruginosa
|
5 pathogens
|
4 pathogens
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=266 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=132 pathogens
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.
|
|---|---|---|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Citrobacter freundii complex
|
1 pathogens
|
2 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Citrobacter koseri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Enterobacter cloacae complex
|
12 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Escherichia coli
|
130 pathogens
|
56 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Klebsiella aerogenes
|
0 pathogens
|
0 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Klebsiella oxytoca
|
3 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Klebsiella pneumoniae
|
29 pathogens
|
14 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Klebsiella variicola
|
1 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Kluyvera ascorbata
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Morganella morganii
|
2 pathogens
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Proteus hauseri
|
0 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Proteus mirabilis
|
6 pathogens
|
6 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Proteus penneri
|
1 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Proteus vulgaris
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Providencia rettgeri
|
—
|
1 pathogens
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Serratia marcescens
|
2 pathogens
|
—
|
|
Per-Pathogen Microbiologic Eradication at Late Follow Up (LFU) in the ME Population
Pseudomonas aeruginosa
|
5 pathogens
|
4 pathogens
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=64 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=28 pathogens
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.
|
|---|---|---|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
—
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
|
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
|
100 percentage of pathogen eradication
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=58 Pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=24 Pathogens
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.
|
|---|---|---|
|
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
|
0 percentage of pathogen eradication
|
|
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
|
66.7 percentage of pathogen eradication
|
|
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
|
—
|
|
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
|
66.7 percentage of pathogen eradication
|
|
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
|
0 percentage of pathogen eradication
|
|
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
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=60 pathogens
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=26 pathogens
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.
|
|---|---|---|
|
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
|
0 percentage of pathogen eradication
|
|
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
|
50.0 percentage of pathogen eradication
|
|
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
|
53.3 percentage of pathogen eradication
|
|
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
|
71.4 percentage of pathogen eradication
|
|
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
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Days 1 to 35Population: Patients with at least one TEAE.
Percent of participants experiencing Treatment Emergent Adverse Events (TEAE). Treatment emergent is defined as any event that starts or worsens during or after treatment.
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=440 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=217 Participants
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.
|
|---|---|---|
|
Number of Patients With Treatment-Emergent Adverse Events
|
156 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Study Days 1 to 35Population: Patients with at least one treatment-emergent SAE.
Percent of participants experiencing treatment emergent Serious Adverse Events (SAE).
Outcome measures
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=440 Participants
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period.
Cefepime/VNRX-5133 (taniborbactam): Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
|
Meropenem
n=217 Participants
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.
|
|---|---|---|
|
Number of Patients With Serious Adverse Events
|
9 Participants
|
4 Participants
|
Adverse Events
Cefepime/VNRX-5133 (Taniborbactam)
Meropenem
Serious adverse events
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=440 participants at risk
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients also received meropenem placebo administered via IV over a 2-hour period.
|
Meropenem
n=217 participants at risk
Meropenem administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients also received cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.45%
2/440 • Number of events 2 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Appendicitis
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Endocarditis
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Renal abscess
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Urinary tract infection
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/440 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.92%
2/217 • Number of events 2 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/440 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/440 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
General disorders
Death
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/440 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Vascular disorders
Hypertension
|
0.23%
1/440 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.00%
0/217 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
Other adverse events
| Measure |
Cefepime/VNRX-5133 (Taniborbactam)
n=440 participants at risk
Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients also received meropenem placebo administered via IV over a 2-hour period.
|
Meropenem
n=217 participants at risk
Meropenem administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients also received cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.1%
27/440 • Number of events 27 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
3.7%
8/217 • Number of events 8 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
18/440 • Number of events 18 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
2.3%
5/217 • Number of events 5 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Constipation
|
3.2%
14/440 • Number of events 14 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
1.4%
3/217 • Number of events 3 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Vascular disorders
Hypertension
|
2.0%
9/440 • Number of events 10 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.92%
2/217 • Number of events 2 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Nausea
|
2.0%
9/440 • Number of events 9 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.92%
2/217 • Number of events 2 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
7/440 • Number of events 7 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
1.4%
3/217 • Number of events 3 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
6/440 • Number of events 7 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
1.4%
3/217 • Number of events 3 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Nervous system disorders
Dizziness
|
1.6%
7/440 • Number of events 7 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.6%
7/440 • Number of events 7 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Vascular disorders
Phlebitis
|
1.4%
6/440 • Number of events 6 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
6/440 • Number of events 6 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.46%
1/217 • Number of events 1 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
5/440 • Number of events 5 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
0.92%
2/217 • Number of events 2 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
General disorders
Pyrexia
|
1.1%
5/440 • Number of events 5 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
1.4%
3/217 • Number of events 3 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
|
Investigations
Alanine aminotransferase increased
|
0.91%
4/440 • Number of events 4 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
2.3%
5/217 • Number of events 5 • From first dose to last follow-up visit (Day 28-35).
Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in patients who received at least one dose of study drug (Safety Population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Certain PIs are not allowed to present or publish data from the Study without Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER