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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| co-administration of cefepime and nacubactam | Experimental | co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion) |
|
| co-administration of aztreonam and nacubactam | Experimental | co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion) |
|
| imipenem/cilastatin | Active Comparator | combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| co-administration of cefepime and nacubactam | Drug | 2 g cefepime and 1 g nacubactam |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meiji Research Site | Pleven | Bulgaria | ||||
| Meiji Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42134354 | Derived | Takahashi S, Tateda K, Yanagihara K, Huang H, Doi Y, Yasuda M, Matsumoto K, Sumiya M, Takaya R, Suwada K, Kamiyabu S, Sasagawa Y, Minamida T, Kato S, Kondo K, Naruse T, Mikamo H. Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial. Lancet. 2026 May 16;407(10542):1929-1940. doi: 10.1016/S0140-6736(26)00596-9. |
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A total of 678 patients were screened at 66 sites in 9 countries and 614 patients were radomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 20, 2023 | Oct 29, 2025 |
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| co-administration of aztreonam and nacubactam | Drug | 2 g aztreonama and 1 g nacubactam |
|
| imipenem/cilastatin | Drug | 1 g imipenem/1 g cilastatin |
|
| 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| 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. | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| 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. | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| 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. | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| Rousse |
| Bulgaria |
| Meiji Research Site | Silistra | Bulgaria |
| Meiji Research Site | Sofia | Bulgaria |
| Meiji Research Site | Beijing | China |
| Meiji Research Site | Changchun | China |
| Meiji Research Site | Chongqing | China |
| Meiji Research Site | Fuyang | China |
| Meiji Research Site | Ganzhou | China |
| Meiji Research Site | Huaian | China |
| Meiji Research Site | Huzhou | China |
| Meiji Research Site | Nanchang | China |
| Meiji Research Site | Nanning | China |
| Meiji Research Site | Quanzhou | China |
| Meiji Research Site | Shanghai | China |
| Meiji Research Site | Shantou | China |
| Meiji Research Site | Shijiazhuang | China |
| Meiji Research Site | Taian | China |
| Meiji Research Site | Tianjin | China |
| Meiji Research Site | Xuancheng | China |
| Meiji Research Site | Yunnan | China |
| Meiji Research Site | Zhejiang | China |
| Meiji Research Site | Zhengzhou | China |
| Meiji Research Site | Hradec Králové | Czechia |
| Meiji Research Site | Liberec | Czechia |
| Meiji Research Site | Prague | Czechia |
| Meiji Research Site | Ústà nad Labem | Czechia |
| Meiji Research Site | Meegomäe | Võrumaa | Estonia |
| Meiji Research Site | Kohtla-Järve | Estonia |
| Meiji Research Site | Tallinn | Estonia |
| Meiji Research Site | Tartu | Estonia |
| Meiji Research Site | Kutaisi | Georgia |
| Meiji Research Site | Rustavi | Georgia |
| Meiji Research Site | Tbilisi | Georgia |
| Meiji Research Site | Fukuyama | Japan |
| Meiji Research Site | Gifu | Japan |
| Meiji Research Site | Ibaraki-Town, Higashiibaraki-County | Japan |
| Meiji Research Site | Iwakuni | Japan |
| Meiji Research Site | Kanazawa | Japan |
| Meiji Research Site | Kawachi-Nagano | Japan |
| Meiji Research Site | Kofu | Japan |
| Meiji Research Site | Kumamoto | Japan |
| Meiji Research Site | Matsumoto | Japan |
| Meiji Research Site | Mizumaki-Town, Onga-County | Japan |
| Meiji Research Site | Nagasaki | Japan |
| Meiji Research Site | Nankoku | Japan |
| Meiji Research Site | ÅŒita | Japan |
| Meiji Research Site | ÅŒtake | Japan |
| Meiji Research Site | Sagamihara | Japan |
| Meiji Research Site | Sapporo | Japan |
| Meiji Research Site | Shinjuku-ku | Japan |
| Meiji Research Site | Toyota | Japan |
| Meiji Research Site | Ueda | Japan |
| Meiji Research Site | Yokohama | Japan |
| Meiji Research Site | Riga | Latvia |
| Meiji Research Site | Valmiera | Latvia |
| Meiji Research Site | Kaunas | Lithuania |
| Meiji Research Site | Vilnius | Lithuania |
| Meiji Research Site | Galanta | Slovakia |
| Meiji Research Site | Rimavská Sobota | Slovakia |
| Meiji Research Site | SvidnÃk | Slovakia |
| FG002 | 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 |
| Treated |
|
| Completed Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
m-MITT population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Primary infection type collected in eCRF | Count of Participants | Participants |
| ||||||||||||||||
| Creatinine Clearance (CrCl) at baseline | Mean | Standard Deviation | mL/min |
| |||||||||||||||
| Creatinine Clearance (CrCl) group | Count of Participants | Participants |
| ||||||||||||||||
| Patients with secondary bacteremia at baseline | Count of Participants | Participants |
| ||||||||||||||||
| Prior short-acting antibacterial therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Microbiological Modified Intent-to-Treat (m-MITT) Population | Posted | Count of Participants | Participants | TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment] |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | m-MITT Population | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | m-MITT Population | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | m-MITT Population | Posted | Count of Participants | Participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients with secondary bacteremia at baseline in m-MITT Population | Posted | Count of Participants | Participants | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients with secondary bacteremia at baseline in m-MITT Population | Posted | Count of Participants | Participants | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients with secondary bacteremia at baseline in m-MITT Population | Posted | Count of Participants | Participants | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Patients with secondary bacteremia at baseline in m-MITT Population | Posted | Count of Participants | Participants | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment |
|
Up to follow-up visit (maximum Day 30)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 306 | 6 | 306 | 100 | 306 |
| EG001 | 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 | 0 | 152 | 4 | 152 | 45 | 152 |
| EG002 | 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 | 0 | 150 | 5 | 150 | 65 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Any AEs with frequency less than 2% | General disorders | MedDRA version 26.0 | Systematic Assessment |
|
The analysis plan included subgroup analyses by pathogen for some secondary endpoints. However, there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset. Therefore, we present the results of subgroup analyses for only the two most frequent pathogens, as analyses for the others were considered statistically unreliable and clinically uninformative.
The following contract has been concluded with the sites in the clinical trial agreement:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meiji Seika Pharma Clinical Trial Administrator | Clinical Development Department | (+81) 3-3273-3745 | clinical-trials@meiji.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2025 | Nov 10, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000608518 | nacubactam |
| D000077728 | Cilastatin, Imipenem Drug Combination |
| ID | Term |
|---|---|
| D015378 | Imipenem |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian-Chinese |
|
| Asian-other |
|
| White |
|
| 65 - 74 Years |
|
| >=75 years |
|
| Not Hispanic or Latino |
|
| Unknown |
|
| China |
|
| Other |
|
| Acute Uncomplicated Pyelonephritis (AP) |
|
| >=30 and <60 |
|
| >=60 and <90 |
|
| >=90 and <=240 |
|
| >240 |
|
| Data not collected for Creatinine Clearance (CrCl) at baseline |
|
| No |
|
| No |
|
| If non-inferiority of the cefepime/nacubactam group is declared, a non-inferiority hypothesis test for the aztreonam/nacubactam group will be performed. For this analysis, the same approach as that used for the cefepime/nacubactam group will be used. | Difference in success proportion | 11.4 | 2-Sided | 95 | -1.2 | 23.7 | Miettinen-Nurminen confidence interval | Non-Inferiority | Non-inferirority margin = 15.0% |
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
| OG002 | 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 |
|
|
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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
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| OG002 | 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 |
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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 |
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