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)
NCT ID: 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
| 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
| 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
| 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
|
Total
n=431 Participants
Total of all reporting groups
|
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
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=9 Participants
|
182 Participants
n=17 Participants
|
99 Participants
n=9 Participants
|
42 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
64 Participants
n=9 Participants
|
249 Participants
n=17 Participants
|
115 Participants
n=9 Participants
|
70 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=9 Participants
|
203 Participants
n=17 Participants
|
103 Participants
n=9 Participants
|
51 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=9 Participants
|
228 Participants
n=17 Participants
|
111 Participants
n=9 Participants
|
61 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian-Japanese
|
5 Participants
n=9 Participants
|
23 Participants
n=17 Participants
|
12 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian-Chinese
|
7 Participants
n=9 Participants
|
39 Participants
n=17 Participants
|
23 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · Asian-other
|
0 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race, Customized · White
|
93 Participants
n=9 Participants
|
368 Participants
n=17 Participants
|
179 Participants
n=9 Participants
|
96 Participants
n=6 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 15.57 • n=9 Participants
|
64.8 years
STANDARD_DEVIATION 14.83 • n=17 Participants
|
63.6 years
STANDARD_DEVIATION 14.83 • n=9 Participants
|
66.4 years
STANDARD_DEVIATION 14.04 • n=6 Participants
|
|
Age, Customized
Age, Customized · <65 years
|
41 Participants
n=9 Participants
|
182 Participants
n=17 Participants
|
99 Participants
n=9 Participants
|
42 Participants
n=6 Participants
|
|
Age, Customized
Age, Customized · 65 - 74 Years
|
32 Participants
n=9 Participants
|
130 Participants
n=17 Participants
|
62 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
|
Age, Customized
Age, Customized · >=75 years
|
32 Participants
n=9 Participants
|
119 Participants
n=17 Participants
|
53 Participants
n=9 Participants
|
34 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, Customized · Hispanic or Latino
|
2 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, Customized · Not Hispanic or Latino
|
103 Participants
n=9 Participants
|
427 Participants
n=17 Participants
|
212 Participants
n=9 Participants
|
112 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity, Customized · Unknown
|
0 Participants
n=9 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Japan
|
5 Participants
n=9 Participants
|
23 Participants
n=17 Participants
|
12 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
|
Region of Enrollment
China
|
7 Participants
n=9 Participants
|
40 Participants
n=17 Participants
|
23 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
|
Region of Enrollment
Other
|
93 Participants
n=9 Participants
|
368 Participants
n=17 Participants
|
179 Participants
n=9 Participants
|
96 Participants
n=6 Participants
|
|
Primary infection type collected in eCRF
Complicated Urinary Tract Infection (cUTI)
|
73 Participants
n=9 Participants
|
286 Participants
n=17 Participants
|
137 Participants
n=9 Participants
|
76 Participants
n=6 Participants
|
|
Primary infection type collected in eCRF
Acute Uncomplicated Pyelonephritis (AP)
|
32 Participants
n=9 Participants
|
145 Participants
n=17 Participants
|
77 Participants
n=9 Participants
|
36 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) at baseline
|
82.0 mL/min
STANDARD_DEVIATION 32.43 • n=9 Participants
|
85.9 mL/min
STANDARD_DEVIATION 35.78 • n=17 Participants
|
86.9 mL/min
STANDARD_DEVIATION 34.94 • n=9 Participants
|
87.8 mL/min
STANDARD_DEVIATION 40.1 • n=6 Participants
|
|
Creatinine Clearance (CrCl) group
<30
|
0 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) group
>=30 and <60
|
27 Participants
n=9 Participants
|
103 Participants
n=17 Participants
|
46 Participants
n=9 Participants
|
30 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) group
>=60 and <90
|
44 Participants
n=9 Participants
|
151 Participants
n=17 Participants
|
77 Participants
n=9 Participants
|
30 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) group
>=90 and <=240
|
33 Participants
n=9 Participants
|
170 Participants
n=17 Participants
|
88 Participants
n=9 Participants
|
49 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) group
>240
|
0 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Creatinine Clearance (CrCl) group
Data not collected for Creatinine Clearance (CrCl) at baseline
|
1 Participants
n=9 Participants
|
3 Participants
n=17 Participants
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
|
Patients with secondary bacteremia at baseline
Yes
|
10 Participants
n=9 Participants
|
34 Participants
n=17 Participants
|
15 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
|
Patients with secondary bacteremia at baseline
No
|
95 Participants
n=9 Participants
|
397 Participants
n=17 Participants
|
199 Participants
n=9 Participants
|
103 Participants
n=6 Participants
|
|
Prior short-acting antibacterial therapy
Yes
|
12 Participants
n=9 Participants
|
42 Participants
n=17 Participants
|
18 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
|
Prior short-acting antibacterial therapy
No
|
93 Participants
n=9 Participants
|
389 Participants
n=17 Participants
|
196 Participants
n=9 Participants
|
100 Participants
n=6 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
| 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
|
|---|---|---|---|
|
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
|
176 Participants
|
81 Participants
|
64 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 Day30Population: 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
| 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
|
|---|---|---|---|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at EOT (End of Treatment visit)
|
199 Participants
|
102 Participants
|
94 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae
|
30 Participants
|
10 Participants
|
16 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli
|
112 Participants
|
57 Participants
|
44 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at EA (Early Assessment visit)
|
201 Participants
|
110 Participants
|
96 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at FUP (Follow-up visit)
|
147 Participants
|
73 Participants
|
65 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli
|
135 Participants
|
62 Participants
|
45 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae
|
27 Participants
|
11 Participants
|
9 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli
|
151 Participants
|
81 Participants
|
66 Participants
|
|
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae
|
20 Participants
|
9 Participants
|
11 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 Day30Population: 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
| 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
|
|---|---|---|---|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EA
|
9 Participants
|
4 Participants
|
2 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae
|
31 Participants
|
11 Participants
|
16 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli
|
148 Participants
|
82 Participants
|
67 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli
|
143 Participants
|
78 Participants
|
62 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at TOC
|
195 Participants
|
103 Participants
|
92 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at FUP
|
188 Participants
|
98 Participants
|
89 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EOT
|
204 Participants
|
106 Participants
|
100 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EA by baseline pathogen: Escherichia coli
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli
|
155 Participants
|
84 Participants
|
71 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae
|
30 Participants
|
11 Participants
|
13 Participants
|
|
Proportion of Patients With a Clinical Outcome of Cure
Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae
|
28 Participants
|
11 Participants
|
15 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 Day30Population: 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
| 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
|
|---|---|---|---|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at TOC
|
184 Participants
|
83 Participants
|
67 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae
|
27 Participants
|
11 Participants
|
10 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli
|
119 Participants
|
58 Participants
|
46 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae
|
22 Participants
|
9 Participants
|
12 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EA
|
205 Participants
|
112 Participants
|
97 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EOT
|
203 Participants
|
105 Participants
|
95 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at FUP
|
157 Participants
|
75 Participants
|
68 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli
|
155 Participants
|
89 Participants
|
71 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae
|
30 Participants
|
12 Participants
|
13 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli
|
154 Participants
|
83 Participants
|
67 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae
|
30 Participants
|
11 Participants
|
16 Participants
|
|
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli
|
141 Participants
|
63 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatmentPopulation: 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.
Outcome measures
| Measure |
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
|
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
|
|---|---|---|---|
|
Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline
|
12 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatmentPopulation: 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. 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
| Measure |
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
|
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
|
|---|---|---|---|
|
Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline
|
12 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatmentPopulation: 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
| Measure |
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
|
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
|
|---|---|---|---|
|
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
|
11 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatmentPopulation: 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
| Measure |
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
|
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
|
|---|---|---|---|
|
Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC
|
12 Participants
|
8 Participants
|
6 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
| 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
|
|---|---|---|---|
|
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)
|
|
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)
|
|
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
| 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