Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
Conditions
Keywords
OP0595, nacubactam, Integral
Brief summary
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
Interventions
2 g cefepime and 1 g nacubactam
2 g aztreonama and 1 g nacubactam
1 g imipenem/1 g cilastatin
Sponsors
Meiji Seika Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period; 2. Weight at most 140 kg; 3. Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;
Exclusion criteria
1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10\^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion. 2. Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion. 3. Has only a known Gram-positive primary uropathogen (at least 10\^5 CFU/mL), isolated from study qualifying urine culture;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment] | Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With a Clinical Outcome of Cure | 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 | 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. |
| Proportion of Patients With a Microbiological Outcome of Eradication | 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 | 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. |
| Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment | 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. |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | 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 | 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. |
| 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 | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment | 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. |
| Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment | 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. |
| Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment | 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. |
Countries
Bulgaria, China, Czechia, Estonia, Georgia, Japan, Latvia, Lithuania, Slovakia
Participant flow
Recruitment details
A total of 678 patients were screened at 66 sites in 9 countries and 614 patients were radomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 214 |
| 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 | 112 |
| 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 | 105 |
| Total | 431 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 1 | 1 |
| Overall Study | Grew only a Gram-negative organism resistant to imipenem and/or meropenem | 0 | 0 | 1 |
| Overall Study | Ineligibility after the start of the study | 4 | 1 | 0 |
| Overall Study | Other Reason | 3 | 3 | 3 |
| Overall Study | Physician Decision | 4 | 1 | 0 |
| 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 | Subject non-compliance | 4 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | Cefepime/Nacubactam | Aztreonam/Nacubactam | Imipenem/Cilastatin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 115 Participants | 70 Participants | 64 Participants | 249 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 42 Participants | 41 Participants | 182 Participants |
| Age, Continuous | 63.6 years STANDARD_DEVIATION 14.83 | 66.4 years STANDARD_DEVIATION 14.04 | 65.5 years STANDARD_DEVIATION 15.57 | 64.8 years STANDARD_DEVIATION 14.83 |
| Age, Customized Age, Customized 65 - 74 Years | 62 Participants | 36 Participants | 32 Participants | 130 Participants |
| Age, Customized Age, Customized <65 years | 99 Participants | 42 Participants | 41 Participants | 182 Participants |
| Age, Customized Age, Customized >=75 years | 53 Participants | 34 Participants | 32 Participants | 119 Participants |
| Creatinine Clearance (CrCl) at baseline | 86.9 mL/min STANDARD_DEVIATION 34.94 | 87.8 mL/min STANDARD_DEVIATION 40.1 | 82.0 mL/min STANDARD_DEVIATION 32.43 | 85.9 mL/min STANDARD_DEVIATION 35.78 |
| Creatinine Clearance (CrCl) group >240 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Creatinine Clearance (CrCl) group <30 | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Creatinine Clearance (CrCl) group >=30 and <60 | 46 Participants | 30 Participants | 27 Participants | 103 Participants |
| Creatinine Clearance (CrCl) group >=60 and <90 | 77 Participants | 30 Participants | 44 Participants | 151 Participants |
| Creatinine Clearance (CrCl) group >=90 and <=240 | 88 Participants | 49 Participants | 33 Participants | 170 Participants |
| Creatinine Clearance (CrCl) group Data not collected for Creatinine Clearance (CrCl) at baseline | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Patients with secondary bacteremia at baseline No | 199 Participants | 103 Participants | 95 Participants | 397 Participants |
| Patients with secondary bacteremia at baseline Yes | 15 Participants | 9 Participants | 10 Participants | 34 Participants |
| Primary infection type collected in eCRF Acute Uncomplicated Pyelonephritis (AP) | 77 Participants | 36 Participants | 32 Participants | 145 Participants |
| Primary infection type collected in eCRF Complicated Urinary Tract Infection (cUTI) | 137 Participants | 76 Participants | 73 Participants | 286 Participants |
| Prior short-acting antibacterial therapy No | 196 Participants | 100 Participants | 93 Participants | 389 Participants |
| Prior short-acting antibacterial therapy Yes | 18 Participants | 12 Participants | 12 Participants | 42 Participants |
| Race/Ethnicity, Customized Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity, Customized Not Hispanic or Latino | 212 Participants | 112 Participants | 103 Participants | 427 Participants |
| Race/Ethnicity, Customized Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized Asian-Chinese | 23 Participants | 9 Participants | 7 Participants | 39 Participants |
| Race/Ethnicity, Customized Race, Customized Asian-Japanese | 12 Participants | 6 Participants | 5 Participants | 23 Participants |
| Race/Ethnicity, Customized Race, Customized Asian-other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized White | 179 Participants | 96 Participants | 93 Participants | 368 Participants |
| Region of Enrollment China | 23 Participants | 10 Participants | 7 Participants | 40 Participants |
| Region of Enrollment Japan | 12 Participants | 6 Participants | 5 Participants | 23 Participants |
| Region of Enrollment Other | 179 Participants | 96 Participants | 93 Participants | 368 Participants |
| Sex: Female, Male Female | 103 Participants | 51 Participants | 49 Participants | 203 Participants |
| Sex: Female, Male Male | 111 Participants | 61 Participants | 56 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 306 | 0 / 152 | 0 / 150 |
| other Total, other adverse events | 100 / 306 | 45 / 152 | 65 / 150 |
| serious Total, serious adverse events | 6 / 306 | 4 / 152 | 5 / 150 |
Outcome results
Primary
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
Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/Nacubactam | 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 |
| Aztreonam/Nacubactam | 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 | 81 Participants |
| Imipenem/Cilastatin | 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 |
95% CI: [10.9, 32]
95% CI: [-1.2, 23.7]
Secondary
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP (Follow-up visit) | 147 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EA (Early Assessment visit) | 201 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli | 135 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae | 20 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli | 112 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae | 27 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT (End of Treatment visit) | 199 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae | 30 Participants |
| Cefepime/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli | 151 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP (Follow-up visit) | 73 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT (End of Treatment visit) | 102 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae | 10 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli | 57 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae | 9 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli | 81 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli | 62 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EA (Early Assessment visit) | 110 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EA (Early Assessment visit) | 96 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT (End of Treatment visit) | 94 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP (Follow-up visit) | 65 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli | 45 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae | 9 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli | 66 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae | 16 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli | 44 Participants |
Comparison: Composite clinical and microbiological success at EA95% CI: [-3.2, 9.9]
Comparison: Composite clinical and microbiological success at EA95% CI: [1.1, 14]
Comparison: Composite clinical and microbiological success at EOT95% CI: [-2.7, 11.3]
Comparison: Composite clinical and microbiological success at EOT95% CI: [-6.6, 10]
Comparison: Composite clinical and microbiological success at FUP95% CI: [-4.1, 18.1]
Comparison: Composite clinical and microbiological success at FUP95% CI: [-9.5, 16]
Comparison: Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli95% CI: [12, 36.6]
Comparison: Composite clinical and microbiological success at TOC by baseline pathogen: Escherichia coli95% CI: [-4.2, 24.9]
Comparison: Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [1.8, 54.1]
Comparison: Composite clinical and microbiological success at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [1.1, 61.6]
Comparison: Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli95% CI: [-1.3, 16.3]
Comparison: Composite clinical and microbiological success at EOT by baseline pathogen: Escherichia coli95% CI: [-5.6, 14.7]
Comparison: Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-20.3, 13.9]
Comparison: Composite clinical and microbiological success at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-45.4, 5.2]
Comparison: Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli95% CI: [-1.7, 24.4]
Comparison: Composite clinical and microbiological success at FUP by baseline pathogen: Escherichia coli95% CI: [-8.7, 20.9]
Comparison: Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-31.9, 23.1]
Comparison: Composite clinical and microbiological success at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-28.8, 37.9]
Secondary
Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC | 12 Participants |
| Aztreonam/Nacubactam | Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC | 8 Participants |
| Imipenem/Cilastatin | Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC | 6 Participants |
95% CI: [-16, 54.3]
95% CI: [-13, 62.1]
Secondary
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
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/Nacubactam | 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 |
| Aztreonam/Nacubactam | 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 | 4 Participants |
| Imipenem/Cilastatin | 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 |
95% CI: [12.8, 78.1]
95% CI: [-18.4, 60.5]
Secondary
Proportion of Patients With a Clinical Outcome of Cure
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT | 204 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli | 148 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae | 30 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC | 195 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae | 28 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA | 9 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli | 143 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP | 188 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Escherichia coli | 5 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae | 31 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae | 2 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli | 155 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT | 106 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli | 84 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli | 82 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP | 98 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA | 4 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli | 78 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC | 103 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae | 1 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Escherichia coli | 3 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae | 15 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae | 0 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA | 2 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT | 100 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC | 92 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP | 89 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EA by baseline pathogen: Escherichia coli | 1 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli | 71 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae | 16 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli | 67 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae | 13 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure | Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli | 62 Participants |
Comparison: Clinical outcome of cure at EA95% CI: [-2.8, 6.3]
Comparison: Clinical outcome of cure at EA95% CI: [-3.5, 7.2]
Comparison: Clinical outcome of cure at EOT95% CI: [-4.6, 6.4]
Comparison: Clinical outcome of cure at EOT95% CI: [-7.1, 6]
Comparison: Clinical outcome of cure at TOC95% CI: [-3.3, 11.8]
Comparison: Clinical outcome of cure at TOC95% CI: [-3.9, 13]
Comparison: Clinical outcome of cure at FUP95% CI: [-4.5, 12.1]
Comparison: Clinical outcome of cure at FUP95% CI: [-6.6, 12.3]
Comparison: Clinical outcome of cure at EA by baseline pathogen: Escherichia coli95% CI: [-4.2, 6]
Comparison: Clinical outcome of cure at EA by baseline pathogen: Escherichia coli95% CI: [-4.1, 8.3]
Comparison: Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae95% CI: [-13.9, 20.3]
Comparison: Clinical outcome of cure at EA by baseline pathogen: Klebsiella pneumoniae95% CI: [-12.6, 36]
Comparison: Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli95% CI: [-3.5, 10.5]
Comparison: Clinical outcome of cure at EOT by baseline pathogen: Escherichia coli95% CI: [-6.9, 9.6]
Comparison: Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-15.9, 16.8]
Comparison: Clinical outcome of cure at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-36, 12.6]
Comparison: Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli95% CI: [-4.5, 13.1]
Comparison: Clinical outcome of cure at TOC by baseline pathogen: Escherichia coli95% CI: [-5.3, 14.2]
Comparison: Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [-6, 38]
Comparison: Clinical outcome of cure at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [-20.5, 37.3]
Comparison: Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli95% CI: [-2.6, 17.8]
Comparison: Clinical outcome of cure at FUP by baseline pathogen: Escherichia coli95% CI: [-5, 17.8]
Comparison: Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-23.6, 17.6]
Comparison: Clinical outcome of cure at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-30.9, 22.3]
Secondary
Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline | 12 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline | 8 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline | 6 Participants |
95% CI: [-16, 54.3]
95% CI: [-13, 62.1]
Secondary
Proportion of Patients With a Microbiological Outcome of Eradication
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC | 184 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli | 119 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA | 205 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT | 203 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP | 157 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli | 155 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae | 30 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli | 154 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae | 30 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli | 141 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae | 27 Participants |
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae | 22 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP | 75 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli | 58 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae | 9 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae | 12 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae | 11 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA | 112 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli | 63 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli | 89 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT | 105 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli | 83 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC | 83 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli | 67 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP | 68 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli | 71 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli | 47 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae | 13 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli | 46 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC | 67 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae | 10 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae | 12 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EA | 97 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae | 16 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication | Microbiological outcome of eradication at EOT | 95 Participants |
Comparison: Microbiological outcome of eradication at EA95% CI: [-1.7, 10.5]
Comparison: Microbiological outcome of eradication at EA95% CI: [3.9, 14.3]
Comparison: Microbiological outcome of eradication at EOT95% CI: [-1.3, 11.9]
Comparison: Microbiological outcome of eradication at EOT95% CI: [-4.2, 11.2]
Comparison: Microbiological outcome of eradication at TOC95% CI: [12.2, 32.7]
Comparison: Microbiological outcome of eradication at TOC95% CI: [-2, 22.5]
Comparison: Microbiological outcome of eradication at FUP95% CI: [-2, 19.7]
Comparison: Microbiological outcome of eradication at FUP95% CI: [-10.4, 14.8]
Comparison: Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli95% CI: [-3.5, 10.5]
Comparison: Microbiological outcome of eradication at EA by baseline pathogen: Escherichia coli95% CI: [2.3, 14.5]
Comparison: Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae95% CI: [-6, 38]
Comparison: Microbiological outcome of eradication at EA by baseline pathogen: Klebsiella pneumoniae95% CI: [-8.3, 43.5]
Comparison: Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli95% CI: [-0.1, 16.5]
Comparison: Microbiological outcome of eradication at EOT by baseline pathogen: Escherichia coli95% CI: [-3.9, 15.1]
Comparison: Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-20.3, 13.9]
Comparison: Microbiological outcome of eradication at EOT by baseline pathogen: Klebsiella pneumoniae95% CI: [-36, 12.6]
Comparison: Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli95% CI: [13.5, 37.5]
Comparison: Microbiological outcome of eradication at TOC by baseline pathogen: Escherichia coli95% CI: [-5.5, 23.3]
Comparison: Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [-3.4, 48.5]
Comparison: Microbiological outcome of eradication at TOC by baseline pathogen: Klebsiella pneumoniae95% CI: [-4.4, 56]
Comparison: Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli95% CI: [0.3, 25.9]
Comparison: Microbiological outcome of eradication at FUP by baseline pathogen: Escherichia coli95% CI: [-10.1, 19.3]
Comparison: Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-30.4, 22.6]
Comparison: Microbiological outcome of eradication at FUP by baseline pathogen: Klebsiella pneumoniae95% CI: [-34, 31.5]
Secondary
Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cefepime/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline | 12 Participants |
| Aztreonam/Nacubactam | Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline | 8 Participants |
| Imipenem/Cilastatin | Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline | 6 Participants |
95% CI: [-16, 54.3]
95% CI: [-13, 62.1]