Trial Outcomes & Findings for Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis (NCT NCT05887908)

Last Updated: 2025-12-24

Results Overview

Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

614 participants

Primary outcome timeframe

TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment]

Results posted on

2025-12-24

Participant Flow

A total of 678 patients were screened at 66 sites in 9 countries and 614 patients were radomized.

Participant milestones

Participant milestones
Measure	Cefepime/Nacubactam 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Imipenem/Cilastatin 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Overall Study STARTED	309	154	151
Overall Study Treated	307	152	151
Overall Study Completed Study Drug	290	147	143
Overall Study COMPLETED	284	144	139
Overall Study NOT COMPLETED	25	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cefepime/Nacubactam 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Imipenem/Cilastatin 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Overall Study Adverse Event	6	1	1
Overall Study Physician Decision	4	1	0
Overall Study Withdrawal by Subject	3	2	3
Overall Study Ineligibility after the start of the study	4	1	0
Overall Study Subject non-compliance	4	0	4
Overall Study Grew only a Gram-negative organism resistant to imipenem and/or meropenem	0	0	1
Overall Study Pregnancy	0	1	0
Overall Study Required Use of Prohibited Concomitant Medications	1	0	0
Overall Study Significant prolongation of the QT/QTc interval	0	1	0
Overall Study Other Reason	3	3	3

Baseline Characteristics

Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cefepime/Nacubactam n=214 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=112 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Imipenem/Cilastatin n=105 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Total n=431 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Age, Categorical Between 18 and 65 years	99 Participants n=30 Participants	42 Participants n=30 Participants	41 Participants n=60 Participants	182 Participants n=219 Participants
Age, Categorical >=65 years	115 Participants n=30 Participants	70 Participants n=30 Participants	64 Participants n=60 Participants	249 Participants n=219 Participants
Sex: Female, Male Female	103 Participants n=30 Participants	51 Participants n=30 Participants	49 Participants n=60 Participants	203 Participants n=219 Participants
Sex: Female, Male Male	111 Participants n=30 Participants	61 Participants n=30 Participants	56 Participants n=60 Participants	228 Participants n=219 Participants
Race/Ethnicity, Customized Race, Customized · Asian-Japanese	12 Participants n=30 Participants	6 Participants n=30 Participants	5 Participants n=60 Participants	23 Participants n=219 Participants
Race/Ethnicity, Customized Race, Customized · Asian-Chinese	23 Participants n=30 Participants	9 Participants n=30 Participants	7 Participants n=60 Participants	39 Participants n=219 Participants
Race/Ethnicity, Customized Race, Customized · Asian-other	0 Participants n=30 Participants	1 Participants n=30 Participants	0 Participants n=60 Participants	1 Participants n=219 Participants
Race/Ethnicity, Customized Race, Customized · White	179 Participants n=30 Participants	96 Participants n=30 Participants	93 Participants n=60 Participants	368 Participants n=219 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 14.83 • n=30 Participants	66.4 years STANDARD_DEVIATION 14.04 • n=30 Participants	65.5 years STANDARD_DEVIATION 15.57 • n=60 Participants	64.8 years STANDARD_DEVIATION 14.83 • n=219 Participants
Age, Customized Age, Customized · <65 years	99 Participants n=30 Participants	42 Participants n=30 Participants	41 Participants n=60 Participants	182 Participants n=219 Participants
Age, Customized Age, Customized · 65 - 74 Years	62 Participants n=30 Participants	36 Participants n=30 Participants	32 Participants n=60 Participants	130 Participants n=219 Participants
Age, Customized Age, Customized · >=75 years	53 Participants n=30 Participants	34 Participants n=30 Participants	32 Participants n=60 Participants	119 Participants n=219 Participants
Race/Ethnicity, Customized Ethnicity, Customized · Hispanic or Latino	1 Participants n=30 Participants	0 Participants n=30 Participants	2 Participants n=60 Participants	3 Participants n=219 Participants
Race/Ethnicity, Customized Ethnicity, Customized · Not Hispanic or Latino	212 Participants n=30 Participants	112 Participants n=30 Participants	103 Participants n=60 Participants	427 Participants n=219 Participants
Race/Ethnicity, Customized Ethnicity, Customized · Unknown	1 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	1 Participants n=219 Participants
Region of Enrollment Japan	12 Participants n=30 Participants	6 Participants n=30 Participants	5 Participants n=60 Participants	23 Participants n=219 Participants
Region of Enrollment China	23 Participants n=30 Participants	10 Participants n=30 Participants	7 Participants n=60 Participants	40 Participants n=219 Participants
Region of Enrollment Other	179 Participants n=30 Participants	96 Participants n=30 Participants	93 Participants n=60 Participants	368 Participants n=219 Participants
Primary infection type collected in eCRF Complicated Urinary Tract Infection (cUTI)	137 Participants n=30 Participants	76 Participants n=30 Participants	73 Participants n=60 Participants	286 Participants n=219 Participants
Primary infection type collected in eCRF Acute Uncomplicated Pyelonephritis (AP)	77 Participants n=30 Participants	36 Participants n=30 Participants	32 Participants n=60 Participants	145 Participants n=219 Participants
Creatinine Clearance (CrCl) at baseline	86.9 mL/min STANDARD_DEVIATION 34.94 • n=30 Participants	87.8 mL/min STANDARD_DEVIATION 40.1 • n=30 Participants	82.0 mL/min STANDARD_DEVIATION 32.43 • n=60 Participants	85.9 mL/min STANDARD_DEVIATION 35.78 • n=219 Participants
Creatinine Clearance (CrCl) group <30	1 Participants n=30 Participants	3 Participants n=30 Participants	0 Participants n=60 Participants	4 Participants n=219 Participants
Creatinine Clearance (CrCl) group >=30 and <60	46 Participants n=30 Participants	30 Participants n=30 Participants	27 Participants n=60 Participants	103 Participants n=219 Participants
Creatinine Clearance (CrCl) group >=60 and <90	77 Participants n=30 Participants	30 Participants n=30 Participants	44 Participants n=60 Participants	151 Participants n=219 Participants
Creatinine Clearance (CrCl) group >=90 and <=240	88 Participants n=30 Participants	49 Participants n=30 Participants	33 Participants n=60 Participants	170 Participants n=219 Participants
Creatinine Clearance (CrCl) group >240	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=219 Participants
Creatinine Clearance (CrCl) group Data not collected for Creatinine Clearance (CrCl) at baseline	2 Participants n=30 Participants	0 Participants n=30 Participants	1 Participants n=60 Participants	3 Participants n=219 Participants
Patients with secondary bacteremia at baseline Yes	15 Participants n=30 Participants	9 Participants n=30 Participants	10 Participants n=60 Participants	34 Participants n=219 Participants
Patients with secondary bacteremia at baseline No	199 Participants n=30 Participants	103 Participants n=30 Participants	95 Participants n=60 Participants	397 Participants n=219 Participants
Prior short-acting antibacterial therapy Yes	18 Participants n=30 Participants	12 Participants n=30 Participants	12 Participants n=60 Participants	42 Participants n=219 Participants
Prior short-acting antibacterial therapy No	196 Participants n=30 Participants	100 Participants n=30 Participants	93 Participants n=60 Participants	389 Participants n=219 Participants

PRIMARY outcome

Timeframe: TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment]

Population: Microbiological Modified Intent-to-Treat (m-MITT) Population

Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=105 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=214 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=112 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population	64 Participants	176 Participants	81 Participants

SECONDARY outcome

Timeframe: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30

Population: m-MITT Population

Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication. Assessment of clinical outcome was based on Investigator's evaluation of the patient's clinical signs and symptoms, with cure defined as the complete resolution (or return to premorbid state) of the baseline signs and symptoms of cUTI or AP that were present at screening, such that no further antimicrobial therapy is warranted. Microbiological outcome was determined programmatically based on quantitative microbiological urine cultures, with eradication defined as the pathogen found at screening with 10\^5 CFU/ml or more reduced to less than 10\^3 CFU/ml. The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=105 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=214 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=112 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at EA (Early Assessment visit)	96 Participants	201 Participants	110 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at EOT (End of Treatment visit)	94 Participants	199 Participants	102 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at FUP (Follow-up visit)	65 Participants	147 Participants	73 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae	9 Participants	27 Participants	11 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae	16 Participants	30 Participants	10 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli	44 Participants	112 Participants	57 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli	45 Participants	135 Participants	62 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli	66 Participants	151 Participants	81 Participants
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae	11 Participants	20 Participants	9 Participants

SECONDARY outcome

Population: m-MITT Population

Assessment of clinical outcome was based on Investigator's evaluation of the patient's clinical signs and symptoms, with cure defined as the complete resolution (or return to premorbid state) of the baseline signs and symptoms of cUTI or AP that were present at screening, such that no further antimicrobial therapy is warranted. The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=105 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=214 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=112 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae	16 Participants	31 Participants	11 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at TOC	92 Participants	195 Participants	103 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EA by baseline pathogen: Escherichia coli	1 Participants	5 Participants	3 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae	0 Participants	2 Participants	1 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli	71 Participants	155 Participants	84 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli	67 Participants	148 Participants	82 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae	13 Participants	30 Participants	11 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at FUP	89 Participants	188 Participants	98 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli	62 Participants	143 Participants	78 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae	15 Participants	28 Participants	11 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EA	2 Participants	9 Participants	4 Participants
Proportion of Patients With a Clinical Outcome of Cure Clinical outcome of cure at EOT	100 Participants	204 Participants	106 Participants

SECONDARY outcome

Population: m-MITT Population

Microbiological outcome was determined programmatically based on quantitative microbiological urine cultures, with eradication defined as the pathogen found at screening with 10\^5 CFU/ml or more reduced to less than 10\^3 CFU/ml. The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=105 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=214 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=112 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EOT	95 Participants	203 Participants	105 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae	13 Participants	30 Participants	12 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli	67 Participants	154 Participants	83 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae	16 Participants	30 Participants	11 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli	47 Participants	141 Participants	63 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae	10 Participants	27 Participants	11 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli	46 Participants	119 Participants	58 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae	12 Participants	22 Participants	9 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EA	97 Participants	205 Participants	112 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at TOC	67 Participants	184 Participants	83 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at FUP	68 Participants	157 Participants	75 Participants
Proportion of Patients With a Microbiological Outcome of Eradication Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli	71 Participants	155 Participants	89 Participants

SECONDARY outcome

Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment

Population: Patients with secondary bacteremia at baseline in m-MITT Population

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=10 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=15 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=9 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline	6 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment

Population: Patients with secondary bacteremia at baseline in m-MITT Population

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=10 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=15 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=9 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline	6 Participants	12 Participants	8 Participants

SECONDARY outcome

Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment

Population: Patients with secondary bacteremia at baseline in m-MITT Population

Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia. For cUTI/AP,Assessment is done by the same way as "Proportion of patients who achieve composite clinical and microbiological outcome". For secondary bacteremia, assessment of clinical outcome was based on signs and symptoms, with cure defined as complete resolution or significant improvement of the baseline signs and symptoms of secondary bacteremia. Microbiological outcome will be determined programmatically based on blood cultures, with eradication defined as the pathogen found at screening is negative in blood culture.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=10 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=15 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=9 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients Who Are Free From the Definition of Secondary Bacteremia AND a Clinical Outcome of Cure AND a Microbiological Outcome of Eradication From cUTI or AP at TOC in Patients With Secondary Bacteremia at Baseline	2 Participants	11 Participants	4 Participants

SECONDARY outcome

Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment

Population: Patients with secondary bacteremia at baseline in m-MITT Population

Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia. Assessment of clinical outcome was based on signs and symptoms, with cure defined as complete resolution or significant improvement of the baseline signs and symptoms of secondary bacteremia. Microbiological outcome will be determined programmatically based on blood cultures, with eradication defined as the pathogen found at screening is negative in blood culture.

Outcome measures

Outcome measures
Measure	Imipenem/Cilastatin n=10 Participants 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Cefepime/Nacubactam n=15 Participants 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=9 Participants 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC	6 Participants	12 Participants	8 Participants

Adverse Events

Cefepime/Nacubactam

Serious events: 6 serious events

Other events: 100 other events

Deaths: 1 deaths

Aztreonam/Nacubactam

Serious events: 4 serious events

Other events: 45 other events

Deaths: 0 deaths

Imipenem/Cilastatin

Serious events: 5 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cefepime/Nacubactam n=306 participants at risk 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=152 participants at risk 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Imipenem/Cilastatin n=150 participants at risk 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Renal and urinary disorders Acute kidney injury	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Renal and urinary disorders Hydronephrosis	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Renal and urinary disorders Renal failure	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.67% 1/150 • Number of events 1 • Up to follow-up visit (maximum Day 30)
Hepatobiliary disorders Biliary colic	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Infections and infestations Urinary tract infection	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	1.3% 2/152 • Number of events 2 • Up to follow-up visit (maximum Day 30)	0.67% 1/150 • Number of events 1 • Up to follow-up visit (maximum Day 30)
Infections and infestations COVID-19	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Infections and infestations Orchitis	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.67% 1/150 • Number of events 1 • Up to follow-up visit (maximum Day 30)
General disorders Pyrexia	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	1.3% 2/150 • Number of events 2 • Up to follow-up visit (maximum Day 30)
General disorders Chills	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.67% 1/150 • Number of events 1 • Up to follow-up visit (maximum Day 30)
General disorders Disease progression	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
General disorders Hyperthermia	0.00% 0/306 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.67% 1/150 • Number of events 1 • Up to follow-up visit (maximum Day 30)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Nervous system disorders Encephalopathy	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.00% 0/152 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)

Other adverse events

Other adverse events
Measure	Cefepime/Nacubactam n=306 participants at risk 2 g cefepime/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Aztreonam/Nacubactam n=152 participants at risk 2 g aztreonam/1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes	Imipenem/Cilastatin n=150 participants at risk 1 g imipenem/1 g cilastatin every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes
Gastrointestinal disorders Diarrhoea	4.6% 14/306 • Number of events 14 • Up to follow-up visit (maximum Day 30)	2.0% 3/152 • Number of events 3 • Up to follow-up visit (maximum Day 30)	4.0% 6/150 • Number of events 6 • Up to follow-up visit (maximum Day 30)
Gastrointestinal disorders Nausea	1.6% 5/306 • Number of events 5 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	6.7% 10/150 • Number of events 10 • Up to follow-up visit (maximum Day 30)
Gastrointestinal disorders Constipation	2.0% 6/306 • Number of events 6 • Up to follow-up visit (maximum Day 30)	2.0% 3/152 • Number of events 3 • Up to follow-up visit (maximum Day 30)	2.7% 4/150 • Number of events 6 • Up to follow-up visit (maximum Day 30)
Gastrointestinal disorders Vomiting	0.65% 2/306 • Number of events 2 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	3.3% 5/150 • Number of events 5 • Up to follow-up visit (maximum Day 30)
Gastrointestinal disorders Abdominal pain upper	0.33% 1/306 • Number of events 1 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	2.0% 3/150 • Number of events 3 • Up to follow-up visit (maximum Day 30)
Infections and infestations Asymptomatic bacteriuria	0.98% 3/306 • Number of events 3 • Up to follow-up visit (maximum Day 30)	4.6% 7/152 • Number of events 7 • Up to follow-up visit (maximum Day 30)	3.3% 5/150 • Number of events 5 • Up to follow-up visit (maximum Day 30)
Nervous system disorders Headache	3.3% 10/306 • Number of events 11 • Up to follow-up visit (maximum Day 30)	5.3% 8/152 • Number of events 8 • Up to follow-up visit (maximum Day 30)	4.0% 6/150 • Number of events 6 • Up to follow-up visit (maximum Day 30)
General disorders Pyrexia	1.3% 4/306 • Number of events 4 • Up to follow-up visit (maximum Day 30)	1.3% 2/152 • Number of events 2 • Up to follow-up visit (maximum Day 30)	2.0% 3/150 • Number of events 3 • Up to follow-up visit (maximum Day 30)
Metabolism and nutrition disorders Hypokalaemia	2.0% 6/306 • Number of events 6 • Up to follow-up visit (maximum Day 30)	0.66% 1/152 • Number of events 1 • Up to follow-up visit (maximum Day 30)	1.3% 2/150 • Number of events 2 • Up to follow-up visit (maximum Day 30)
Skin and subcutaneous tissue disorders Rash	0.65% 2/306 • Number of events 2 • Up to follow-up visit (maximum Day 30)	1.3% 2/152 • Number of events 2 • Up to follow-up visit (maximum Day 30)	2.7% 4/150 • Number of events 4 • Up to follow-up visit (maximum Day 30)
Vascular disorders Hypertension	1.6% 5/306 • Number of events 5 • Up to follow-up visit (maximum Day 30)	2.0% 3/152 • Number of events 3 • Up to follow-up visit (maximum Day 30)	0.00% 0/150 • Up to follow-up visit (maximum Day 30)
General disorders Any AEs with frequency less than 2%	13.7% 42/306 • Number of events 42 • Up to follow-up visit (maximum Day 30)	8.6% 13/152 • Number of events 13 • Up to follow-up visit (maximum Day 30)	11.3% 17/150 • Number of events 17 • Up to follow-up visit (maximum Day 30)

Additional Information

Meiji Seika Pharma Clinical Trial Administrator

Clinical Development Department

Phone: (+81) 3-3273-3745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The following contract has been concluded with the sites in the clinical trial agreement: * Information obtained from the results of the trial must not be leaked without the Sponsor's prior written consent. * If information obtained from the trial is to be published outside the institution, such as at an academic conference, prior written consent must be obtained from the Sponsor.
Publication restrictions are in place

Restriction type: OTHER