Trial · NCT05887908
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
NCT05887908, Phase 3, Completed, Meiji Seika Pharma Co., Ltd.; results first posted 2025-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis. Trials, record NCT05887908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05887908
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT05887908
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 614 participants, actual
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
- Interventions
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin
- First posted
- 2023-06-05
- Last updated
- 2025-12-24
- Results first posted
- 2025-11-25
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment] | Microbiological Modified Intent-to-Treat (m-MITT) Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 secondary bacteremia at baseline in m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 secondary bacteremia at baseline in m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| 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 | TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment | Patients with secondary bacteremia at baseline in m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 secondary bacteremia at baseline in m-MITT Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Cefepime/Nacubactam | 176 | Participants | ||
| 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 | Aztreonam/Nacubactam | 81 | Participants | ||
| 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 | Imipenem/Cilastatin | 64 | Participants | ||
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Cefepime/Nacubactam | Composite clinical and microbiological success at EA (Early Assessment visit) | 201 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Aztreonam/Nacubactam | Composite clinical and microbiological success at EA (Early Assessment visit) | 110 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Imipenem/Cilastatin | Composite clinical and microbiological success at EA (Early Assessment visit) | 96 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Cefepime/Nacubactam | Composite clinical and microbiological success at EOT (End of Treatment visit) | 199 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Aztreonam/Nacubactam | Composite clinical and microbiological success at EOT (End of Treatment visit) | 102 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Imipenem/Cilastatin | Composite clinical and microbiological success at EOT (End of Treatment visit) | 94 | Participants | |
| Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome | Cefepime/Nacubactam | Composite clinical and microbiological success at FUP (Follow-up visit) | 147 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cefepime/Nacubactam | 309 | |
| Overall Study | STARTED | Aztreonam/Nacubactam | 154 | |
| Overall Study | STARTED | Imipenem/Cilastatin | 151 | |
| Overall Study | Treated | Cefepime/Nacubactam | 307 | |
| Overall Study | Treated | Aztreonam/Nacubactam | 152 | |
| Overall Study | Treated | Imipenem/Cilastatin | 151 | |
| Overall Study | Completed Study Drug | Cefepime/Nacubactam | 290 | |
| Overall Study | Completed Study Drug | Aztreonam/Nacubactam | 147 | |
| Overall Study | Completed Study Drug | Imipenem/Cilastatin | 143 | |
| Overall Study | COMPLETED | Cefepime/Nacubactam | 284 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Cefepime/Nacubactam | 14 | 306 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Aztreonam/Nacubactam | 3 | 152 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Imipenem/Cilastatin | 6 | 150 | 6 |
| other | Nausea | Gastrointestinal disorders | Cefepime/Nacubactam | 5 | 306 | 5 |
| other | Nausea | Gastrointestinal disorders | Aztreonam/Nacubactam | 1 | 152 | 1 |
| other | Nausea | Gastrointestinal disorders | Imipenem/Cilastatin | 10 | 150 | 10 |
| other | Constipation | Gastrointestinal disorders | Cefepime/Nacubactam | 6 | 306 | 6 |
| other | Constipation | Gastrointestinal disorders | Aztreonam/Nacubactam | 3 | 152 | 3 |
| other | Constipation | Gastrointestinal disorders | Imipenem/Cilastatin | 4 | 150 | 6 |
| other | Vomiting | Gastrointestinal disorders | Cefepime/Nacubactam | 2 | 306 | 2 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cefepime/Nacubactam | 1 | 306 |
| Total, all-cause mortality | Aztreonam/Nacubactam | 0 | 152 |
| Total, all-cause mortality | Imipenem/Cilastatin | 0 | 150 |
| Total, other adverse events | Cefepime/Nacubactam | 100 | 306 |
| Total, other adverse events | Aztreonam/Nacubactam | 45 | 152 |
| Total, other adverse events | Imipenem/Cilastatin | 65 | 150 |
| Total, serious adverse events | Cefepime/Nacubactam | 6 | 306 |
| Total, serious adverse events | Aztreonam/Nacubactam | 4 | 152 |
| Total, serious adverse events | Imipenem/Cilastatin | 5 | 150 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42134354 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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