Trial · NCT02302092
An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
NCT02302092, Phase 3, Terminated, Takeda; results first posted 2017-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections. Trials, record NCT02302092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02302092
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
- NCT number
- NCT02302092
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Urinary Tract Infection
- Interventions
- Flomoxef, Cefepime
- First posted
- 2014-11-26
- Last updated
- 2017-10-27
- Results first posted
- 2017-10-27
- Limitations and caveats
The study is limited as only 13 out of the original 80 participants planned entered the study, due to this none of the planned statistical analyses from the protocol could be carried out, and all results should be reviewed with caution.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit | Baseline and Days 7 to 14 | At the EOT visit (Days 7 to 14), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline. |
| Secondary | Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Baseline, Days 7 to 14 and 14 to 21 | A urine sample was collected at EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine level of uropathogen. Cultures of urine sample were processed by calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10\^4 colony forming units per milliliter (CFU/mL). Microbiological success was defined as bacterial uropathogen level of \<10\^4 CFU/mL. Microbiological response was categorized as:microbiological eradication/persistence/new infection/superinfection. An infection was eradicated if all uropathogens isolated at study entry at a level ≥10\^4 CFU/mL have decreased to \<10\^4 CFU/mL, persistent if level of uropathogen has increased by ≥10\^4 CFU/Ml. A new infection, if there is isolation and growth of a uropathogen other than original pathogen and superinfection if there is growth of a uropathogen other than original pathogen at a level ≥10\^4 CFU/mL. Microbiological success was assessed relative to baseline. |
| Secondary | Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits | Baseline, Days 3, 14 to 21 and 30 | At Visit 3 (Day 3) and at the TOC (Days 14 to 21) and LFU visits (Day 30), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline. |
| Secondary | Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Day 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10\^4 CFU/mL. Microbiological response at the TOC visit was based on the same grades as for the EOT visit. The infection was considered to be eradicated if all uropathogens isolated at study entry at a level equal to or greater than 10\^4 CFU/mL have decreased to less than 10\^4 CFU/mL. |
| Secondary | Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample was processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10\^4 CFU/mL. Microbiological response at the TOC visit was be based on the same grades as for the EOT visit. The infection was considered to be persistent if the level of the uropathogen has increased by greater than or equal to 10\^4 CFU/mL from the time of study entry to that of the EOT and TOC visits. |
| Secondary | Percentage of Participants With a New Infection at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10\^4 CFU/mL. A new infection was defined as the isolation and growth of a uropathogen other than the original pathogen. |
| Secondary | Percentage of Participants With a Superinfection at the EOT and TOC Visits | Baseline, Day 7 to 14 and 14 to 21 | A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10\^4 CFU/mL. A superinfection was defined as growth of a uropathogen other than the original pathogen at a level greater than or equal to 10\^4 CFU/mL at any time during the course of active therapy. |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs) | Baseline up to Day 30 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Values | Day 21 | The number of participants with any markedly abnormal (above or below normal ranges) standard safety laboratory values was collected throughout study. |
| Secondary | Number of Participants With Clinically Significant Change in Vital Signs | Day 1 up to Day 21 | Vital signs included body temperature (axillary measurement), diastolic and systolic blood pressure (5 minutes), respiratory rate, and pulse (bpm). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit | Baseline and Days 7 to 14 | The micro-intent to treat (ITT) population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Baseline, Days 7 to 14 and 14 to 21 | The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits | Baseline, Days 3, 14 to 21 and 30 | The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | Due to premature trial termination and small sample size, data for eradication for particular pathogen numbers in different time periods was not determined. | ||
| SECONDARY | Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | Due to premature trial termination and small sample size, data for persistence of particular pathogen numbers in different time periods was not determined. | ||
| SECONDARY | Percentage of Participants With a New Infection at the EOT and TOC Visits | Baseline, Days 7 to 14 and 14 to 21 | Due to premature trial termination and small sample size, data for new infection due to particular pathogen numbers in different time periods was not determined. | ||
| SECONDARY | Percentage of Participants With a Superinfection at the EOT and TOC Visits | Baseline, Day 7 to 14 and 14 to 21 | Due to premature trial termination and small sample size, data for superinfection due to particular pathogen numbers in different time periods was not determined. | ||
| SECONDARY | Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs) | Baseline up to Day 30 | The safety population included all participants who received any dose of planned study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Abnormal Laboratory Values | Day 21 | The safety population included all participants who received any dose of planned study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Change in Vital Signs | Day 1 up to Day 21 | The safety population included all participants who received any dose of planned study medication. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit | Flomoxef | 60.0 | percentage of participants | ||
| Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit | Cefepime | 42.9 | percentage of participants | ||
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Flomoxef | Days 7 to 14: Eradication | 80.0 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Cefepime | Days 7 to 14: Eradication | 85.7 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Flomoxef | Days 7 to 14: New infection | 0.0 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Cefepime | Days 7 to 14: New infection | 14.3 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Flomoxef | Days 7 to 14: Persistence | 20.0 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Cefepime | Days 7 to 14: Persistence | 14.3 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Flomoxef | Days 7 to 14: Superinfection | 0.0 | percentage of participants | |
| Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits | Cefepime | Days 7 to 14: Superinfection | 14.3 | percentage of participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flomoxef | 6 | |
| Overall Study | STARTED | Cefepime | 7 | |
| Overall Study | COMPLETED | Flomoxef | 6 | |
| Overall Study | COMPLETED | Cefepime | 7 | |
| Overall Study | NOT COMPLETED | Flomoxef | 0 | |
| Overall Study | NOT COMPLETED | Cefepime | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Pyrexia | General disorders | Flomoxef | 0 | 6 | |
| other | Pyrexia | General disorders | Cefepime | 1 | 7 | |
| other | Influenza | Infections and infestations | Flomoxef | 1 | 6 | |
| other | Influenza | Infections and infestations | Cefepime | 0 | 7 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Flomoxef | 0 | 6 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Cefepime | 1 | 7 | |
| other | Thrombophlebitis | Vascular disorders | Flomoxef | 1 | 6 | |
| other | Thrombophlebitis | Vascular disorders | Cefepime | 0 | 7 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flomoxef | ||
| Total, all-cause mortality | Cefepime | ||
| Total, other adverse events | Flomoxef | 2 | 6 |
| Total, other adverse events | Cefepime | 2 | 7 |
| Total, serious adverse events | Flomoxef | 0 | 6 |
| Total, serious adverse events | Cefepime | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Flomoxef vs Cefepime: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02302092
GET https://conductscience.org/api/trials/v1/NCT02302092/results?page=2