Trial Outcomes & Findings for An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections (NCT NCT02302092)
NCT ID: NCT02302092
Last Updated: 2017-10-27
Results Overview
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.
TERMINATED
PHASE3
13 participants
Baseline and Days 7 to 14
2017-10-27
Participant Flow
Participants took part in the study at 4 investigative sites in Russia from 01 December 2015 to 15 Feb 2016.
Participants with a diagnosis of complicated urinary tract infections were enrolled in 1:1 ratio to flomoxef or cefepime arm groups.
Participant milestones
| Measure |
Flomoxef
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
Flomoxef
n=6 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Body mass index
|
25.443 kg/m^2
STANDARD_DEVIATION 4.821 • n=5 Participants
|
31.041 kg/m^2
STANDARD_DEVIATION 8.321 • n=7 Participants
|
28.458 kg/m^2
STANDARD_DEVIATION 7.262 • n=5 Participants
|
|
Smoking status
Non-tobacco user
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Smoking status
Tobacco user
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 7 to 14Population: 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.
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.
Outcome measures
| Measure |
Flomoxef
n=5 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit
|
60.0 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 7 to 14 and 14 to 21Population: 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.
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.
Outcome measures
| Measure |
Flomoxef
n=5 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 14 to 21: Superinfection
|
40.0 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 7 to 14: Eradication
|
80.0 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 7 to 14: New infection
|
0.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 7 to 14: Persistence
|
20.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 7 to 14: Superinfection
|
0.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 14 to 21: Eradication
|
80.0 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 14 to 21: New infection
|
20.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits
Days 14 to 21: Persistence
|
0.0 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 14 to 21 and 30Population: 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.
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.
Outcome measures
| Measure |
Flomoxef
n=5 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits
Days 14 to 21
|
60.0 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits
Day 3
|
0.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits
Day 30
|
60.0 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 7 to 14 and 14 to 21Population: Due to premature trial termination and small sample size, data for eradication for particular pathogen numbers in different time periods was not determined.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Days 7 to 14 and 14 to 21Population: Due to premature trial termination and small sample size, data for persistence of particular pathogen numbers in different time periods was not determined.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Days 7 to 14 and 14 to 21Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 7 to 14 and 14 to 21Population: Due to premature trial termination and small sample size, data for superinfection due to particular pathogen numbers in different time periods was not determined.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 30Population: The safety population included all participants who received any dose of planned study medication.
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.
Outcome measures
| Measure |
Flomoxef
n=6 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs)
SAEs
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs)
TEAEs
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 21Population: The safety population included all participants who received any dose of planned study medication.
The number of participants with any markedly abnormal (above or below normal ranges) standard safety laboratory values was collected throughout study.
Outcome measures
| Measure |
Flomoxef
n=6 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Laboratory Values
Neutrophil count decreased
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Values
White blood cells count increased
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Values
C-reactive Protein level increased
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Values
C-reactive Protein level decreased
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 21Population: The safety population included all participants who received any dose of planned study medication.
Vital signs included body temperature (axillary measurement), diastolic and systolic blood pressure (5 minutes), respiratory rate, and pulse (bpm).
Outcome measures
| Measure |
Flomoxef
n=6 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 3: Pulse Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 7-14: Pulse Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 1: Systolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 3: Systolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 7-14: Systolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 14-21: Systolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 1: Diastolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 3: Diastolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 7-14: Diastolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 14-21: Diastolic Blood Pressure
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 1: Pulse Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 14-21: Pulse Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 1: Respiration Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 3: Respiration Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 7-14: Respiration Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 14-21: Respiration Rate
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 1: Body Temperature
|
2 participants
|
2 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 3: Body Temperature
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 7-14: Body Temperature
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Vital Signs
Day 14-21: Body Temperature
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 21Population: The safety population included all participants who received any dose of planned study medication.
Physical examination consists of examinations of the following body systems: (1) cardiovascular system; (2) dermatologic system (3) ears, nose, throat; (4) extremities; (5) eyes; (6) gastrointestinal system; (7) genitourinary system; (8) lymph nodes; (9) musculoskeletal system; (10) nervous system; (11) respiratory system.
Outcome measures
| Measure |
Flomoxef
n=6 Participants
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 Participants
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Ear/Nose/Tongue
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Extremities
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Extremities
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Lymph nodes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Lymph nodes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Musculoskeletal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Nervous system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Nervous system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Respiratory system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Cardiovascular system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Cardiovascular system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Cardiovascular system
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Cardiovascular system
|
1 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Dermatologic system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Dermatologic system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Dermatologic system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Dermatologic system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Ear/Nose/Tongue
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Ear/Nose/Tongue
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Ear/Nose/Tongue
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Extremities
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Extremities
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Eyes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Eyes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Eyes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 4-21: Eyes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Gastrointestinal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Gastrointestinal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Gastrointestinal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Gastrointestinal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Genitourinary system
|
6 participants
|
7 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Genitourinary system
|
3 participants
|
6 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Genitourinary system
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Genitourinary system
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Lymph nodes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Lymph nodes
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Musculoskeletal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Musculoskeletal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Musculoskeletal system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Nervous system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 14-21: Nervous system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 1: Respiratory system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 3: Respiratory system
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Change in Physical Examination Findings
Day 7-14: Respiratory system
|
0 participants
|
0 participants
|
Adverse Events
Flomoxef
Cefepime
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flomoxef
n=6 participants at risk
Flomoxef, 2g, injection, intravenously, twice daily (every 12 hours) for up to 12 days.
|
Cefepime
n=7 participants at risk
Cefepime, 1g, injection, intravenously, twice daily (every 12 hours) for up to 14 days.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Thrombophlebitis
|
16.7%
1/6 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • Baseline up to Day 30
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER