Trial Outcomes & Findings for Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection (NCT NCT00402727)
NCT ID: NCT00402727
Last Updated: 2014-11-07
Results Overview
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
COMPLETED
PHASE3
813 participants
14 - 28 days after last dose of study medication
2014-11-07
Participant Flow
834 subjects with complicated skin and skin structure infections (cSSSI) enrolled based on evaluation (by interview, medical history, physical examination, and laboratory tests); 21 subjects not randomized, 668 subjects (361 on moxifloxacin, 307 on pipercillin/tazobactam plus amoxicillin/clavulanic acid) included in primary efficacy analysis.
Participant milestones
| Measure |
Moxifloxacin
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Overall Study
STARTED
|
432
|
381
|
|
Overall Study
Achieving End Of Treatment (EOT)
|
408
|
355
|
|
Overall Study
Achieving Test Of Cure (TOC)
|
390
|
347
|
|
Overall Study
COMPLETED
|
390
|
347
|
|
Overall Study
NOT COMPLETED
|
42
|
34
|
Reasons for withdrawal
| Measure |
Moxifloxacin
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
24
|
11
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
supply problems
|
2
|
1
|
|
Overall Study
non-compliance
|
0
|
1
|
Baseline Characteristics
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
Baseline characteristics by cohort
| Measure |
Moxifloxacin
n=432 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=381 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 16 • n=99 Participants
|
54 years
STANDARD_DEVIATION 16 • n=107 Participants
|
53 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=99 Participants
|
123 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
271 Participants
n=99 Participants
|
258 Participants
n=107 Participants
|
529 Participants
n=206 Participants
|
|
Primary diagnosis
Major abscess
|
184 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
354 Participants
n=206 Participants
|
|
Primary diagnosis
Diabetic foot infection
|
123 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
233 Participants
n=206 Participants
|
|
Primary diagnosis
Wound infection
|
72 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Primary diagnosis
Infected ischemic ulcer
|
24 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Primary diagnosis
No cSSSI
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 14 - 28 days after last dose of study medicationPopulation: The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Outcome measures
| Measure |
Moxifloxacin
n=361 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=307 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population
|
88.6 percentage of participants
|
89.6 percentage of participants
|
SECONDARY outcome
Timeframe: 14 - 28 days after last dose of study medicationPopulation: The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as all randomized subject that received at least one dose of study medication and had at least one observation after intake of study drug.
Clinical response was evaluated by the DRC and graded as "cure", "failure" or "indeterminate" at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Outcome measures
| Measure |
Moxifloxacin
n=426 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=377 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population
|
82.2 percentage of participants
|
80.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 - 5 days after start of treatmentPopulation: The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.
Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Outcome measures
| Measure |
Moxifloxacin
n=361 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=307 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population
|
98.3 percentage of participants
|
99.0 percentage of participants
|
SECONDARY outcome
Timeframe: 3 - 5 days after start of treatmentPopulation: The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.
Clinical response was evaluated by the investigator and graded as "improvement in signs and symptoms," or "failure to respond," or "indeterminate" at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs
Outcome measures
| Measure |
Moxifloxacin
n=426 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=377 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population
|
97.2 percentage of participants
|
95.8 percentage of participants
|
SECONDARY outcome
Timeframe: after 7 - 21 days of treatmentPopulation: The per protocol population was the main analysis set for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the primary outcome.
Clinical response was evaluated by the investigator and graded as "resolution," or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Outcome measures
| Measure |
Moxifloxacin
n=361 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=307 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population
|
95.3 percentage of participants
|
95.1 percentage of participants
|
SECONDARY outcome
Timeframe: after 7 - 21 days of treatmentPopulation: The intent-to-treat population was the analysis set used for the assessment of clinical response and was defined as those subject with no major protocol deviations that would have influenced the secondary outcome.
Clinical response was evaluated by the investigator and graded as "resolution", or "failure to respond," or "indeterminate" at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs.
Outcome measures
| Measure |
Moxifloxacin
n=426 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=377 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population
|
92.3 percentage of participants
|
90.7 percentage of participants
|
SECONDARY outcome
Timeframe: 3 - 5 days after start of treatmentPopulation: The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.
Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.
Outcome measures
| Measure |
Moxifloxacin
n=313 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=290 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms
|
54.6 percentage of participants
|
63.1 percentage of participants
|
SECONDARY outcome
Timeframe: 3 - 5 days after start of treatmentPopulation: Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from "indeterminate".
Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism.
Outcome measures
| Measure |
Moxifloxacin
n=268 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=243 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population
|
55.2 percentage of participants
|
63.8 percentage of participants
|
SECONDARY outcome
Timeframe: after 7 - 21 days of treatmentPopulation: The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.
Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.
Outcome measures
| Measure |
Moxifloxacin
n=313 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=290 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms
|
84.0 percentage of participants
|
87.9 percentage of participants
|
SECONDARY outcome
Timeframe: after 7 - 21 days of treatmentPopulation: Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from "indeterminate".
Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism.
Outcome measures
| Measure |
Moxifloxacin
n=230 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=222 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population
|
85.8 percentage of participants
|
91.4 percentage of participants
|
SECONDARY outcome
Timeframe: 14 - 28 days after last dose of study medicationPopulation: The ITT population with causative organism population included all ITT subjects with least one causative organism that could be cultured from an appropriate specimen within 48 hours prior to or following randomization.
BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.
Outcome measures
| Measure |
Moxifloxacin
n=313 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=290 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms
|
78.9 percentage of participants
|
79.0 percentage of participants
|
SECONDARY outcome
Timeframe: 14 - 28 days after last dose of study medicationPopulation: Microbiologically valid subjects were defined as all valid PP subjects in whom at least one causative organism could be cultured from an appropriate specimen within 48 hours prior to or following randomization and where a bacteriological evaluation at TOC visit was available and different from "indeterminate".
BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment.
Outcome measures
| Measure |
Moxifloxacin
n=226 Participants
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=212 Participants
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population
|
84.3 percentage of participants
|
87.2 percentage of participants
|
Adverse Events
Moxifloxacin
PIP/TAZ-AMC
Serious adverse events
| Measure |
Moxifloxacin
n=426 participants at risk
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=377 participants at risk
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/426
|
0.27%
1/377
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.23%
1/426
|
0.00%
0/377
|
|
General disorders
Impaired healing
|
0.00%
0/426
|
0.27%
1/377
|
|
General disorders
Necrosis
|
0.23%
1/426
|
0.00%
0/377
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/426
|
0.27%
1/377
|
|
Infections and infestations
Diabetic gangrene
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Gangrene
|
0.23%
1/426
|
0.80%
3/377
|
|
Infections and infestations
Localised infection
|
0.23%
1/426
|
0.27%
1/377
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Pneumonia
|
0.00%
0/426
|
0.27%
1/377
|
|
Infections and infestations
Pseudomembranous colitis
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Sepsis
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Wound infection
|
0.47%
2/426
|
0.27%
1/377
|
|
Infections and infestations
Urosepsis
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Rectal abscess
|
0.47%
2/426
|
0.00%
0/377
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/426
|
0.27%
1/377
|
|
Infections and infestations
Abscess limb
|
0.23%
1/426
|
0.00%
0/377
|
|
Infections and infestations
Device related infection
|
0.23%
1/426
|
0.00%
0/377
|
|
Investigations
Electrocardiogram QT prolonged
|
0.47%
2/426
|
0.00%
0/377
|
|
Investigations
Blood alkaline phosphatase increased
|
0.23%
1/426
|
0.00%
0/377
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/426
|
0.00%
0/377
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
1/426
|
0.00%
0/377
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.23%
1/426
|
0.00%
0/377
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/426
|
0.27%
1/377
|
|
Psychiatric disorders
Depression
|
0.23%
1/426
|
0.00%
0/377
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/426
|
0.00%
0/377
|
|
Renal and urinary disorders
Renal failure acute
|
0.23%
1/426
|
0.00%
0/377
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.23%
1/426
|
0.27%
1/377
|
|
Surgical and medical procedures
Suture insertion
|
0.23%
1/426
|
0.00%
0/377
|
|
Surgical and medical procedures
Skin implant
|
0.00%
0/426
|
0.27%
1/377
|
|
Vascular disorders
Arterial thrombosis limb
|
0.23%
1/426
|
0.00%
0/377
|
|
Vascular disorders
Shock
|
0.23%
1/426
|
0.00%
0/377
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/426
|
0.27%
1/377
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/426
|
0.27%
1/377
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.23%
1/426
|
0.00%
0/377
|
Other adverse events
| Measure |
Moxifloxacin
n=426 participants at risk
Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
|
PIP/TAZ-AMC
n=377 participants at risk
Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
10/426
|
2.1%
8/377
|
|
Gastrointestinal disorders
Nausea
|
1.2%
5/426
|
0.80%
3/377
|
|
General disorders
Pyrexia
|
1.6%
7/426
|
0.80%
3/377
|
|
Investigations
Electrocardiogram QT prolonged
|
0.23%
1/426
|
1.3%
5/377
|
|
Nervous system disorders
Headache
|
1.2%
5/426
|
0.80%
3/377
|
|
Vascular disorders
Hypertension
|
2.6%
11/426
|
0.53%
2/377
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If Bayer informs coordinating investigator's hospital that such publication could be expected to have an adverse effect on the confidentiality of any confidential information, then the coordinatin investigator's hospital shall prevent the publication, unless the confidential information can be deleted from the publication without having adetrimental effect on the scientific correctness of the publication.
- Publication restrictions are in place
Restriction type: OTHER