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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

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ClinicalTrials.gov Identifier: NCT00402727
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : January 11, 2010
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Abscess
Wound Infection
Diabetic Foot
Ulcer
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
Enrollment 813
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 432 381
Achieving End Of Treatment (EOT) 408 355
Achieving Test Of Cure (TOC) 390 347
Completed 390 347
Not Completed 42 34
Reason Not Completed
Adverse Event             10             6
Death             1             0
Lack of Efficacy             1             3
Lost to Follow-up             24             11
Physician Decision             1             1
Protocol Violation             0             4
Withdrawal by Subject             3             7
supply problems             2             1
non-compliance             0             1
Arm/Group Title Moxifloxacin PIP/TAZ-AMC Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 432 381 813
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 432 participants 381 participants 813 participants
53  (16) 54  (16) 53  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 381 participants 813 participants
Female
161
  37.3%
123
  32.3%
284
  34.9%
Male
271
  62.7%
258
  67.7%
529
  65.1%
Primary diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 432 participants 381 participants 813 participants
Major abscess 184 170 354
Diabetic foot infection 123 110 233
Wound infection 72 55 127
Infected ischemic ulcer 24 18 42
No cSSSI 29 28 57
1.Primary Outcome
Title Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population
Hide Description 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.
Time Frame 14 - 28 days after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 361 307
Measure Type: Number
Unit of Measure: percentage of participants
88.6 89.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population
Method of Estimation Estimation Parameter Difference of cure rates (in percent)
Estimated Value -1.0
Confidence Interval 95%
-5.3 to 3.9
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.
2.Secondary Outcome
Title Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population
Hide Description 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.
Time Frame 14 - 28 days after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 426 377
Measure Type: Number
Unit of Measure: percentage of participants
82.2 80.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of cure rates (in percent)
Estimated Value 1.3
Confidence Interval 95%
-3.8 to 6.3
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
3.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 3 - 5 days after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 361 307
Measure Type: Number
Unit of Measure: percentage of participants
98.3 99.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of improvement rates (in %)
Estimated Value -0.7
Confidence Interval 95%
-1.6 to 0.6
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
4.Secondary Outcome
Title 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
Hide Description 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
Time Frame 3 - 5 days after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 426 377
Measure Type: Number
Unit of Measure: percentage of participants
97.2 95.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of improvement rates (in %)
Estimated Value 1.4
Confidence Interval 95%
-1.3 to 3.9
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
5.Secondary Outcome
Title Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population
Hide Description 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.
Time Frame after 7 - 21 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 361 307
Measure Type: Number
Unit of Measure: percentage of participants
95.3 95.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of resolution rates (in %)
Estimated Value 0.2
Confidence Interval 95%
-3.1 to 2.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
6.Secondary Outcome
Title Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population
Hide Description 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.
Time Frame after 7 - 21 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 426 377
Measure Type: Number
Unit of Measure: percentage of participants
92.3 90.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of resolution rates (in %)
Estimated Value 1.6
Confidence Interval 95%
-2.4 to 5.3
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
7.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms
Hide Description 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.
Time Frame 3 - 5 days after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 313 290
Measure Type: Number
Unit of Measure: percentage of participants
54.6 63.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -8.5
Confidence Interval 95%
-17.0 to -1.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
8.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population
Hide Description 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.
Time Frame 3 - 5 days after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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”.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 268 243
Measure Type: Number
Unit of Measure: percentage of participants
55.2 63.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -8.6
Confidence Interval 95%
-17.6 to -0.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
9.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms
Hide Description 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.
Time Frame after 7 - 21 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 313 290
Measure Type: Number
Unit of Measure: percentage of participants
84.0 87.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -3.9
Confidence Interval 95%
-9.5 to 1.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
10.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population
Hide Description 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.
Time Frame after 7 - 21 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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”.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 230 222
Measure Type: Number
Unit of Measure: percentage of participants
85.8 91.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -5.6
Confidence Interval 95%
-11.4 to -0.8
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
11.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms
Hide Description 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.
Time Frame 14 - 28 days after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 313 290
Measure Type: Number
Unit of Measure: percentage of participants
78.9 79.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -0.1
Confidence Interval 95%
-6.9 to 5.4
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
12.Secondary Outcome
Title Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population
Hide Description 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.
Time Frame 14 - 28 days after last dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
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”.
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 226 212
Measure Type: Number
Unit of Measure: percentage of participants
84.3 87.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, PIP/TAZ-AMC
Comments Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variable.
Method of Estimation Estimation Parameter Difference of eradication rates (in %)
Estimated Value -2.9
Confidence Interval 95%
-9.3 to 2.2
Estimation Comments A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin PIP/TAZ-AMC
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Moxifloxacin PIP/TAZ-AMC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Moxifloxacin PIP/TAZ-AMC
Affected / at Risk (%) Affected / at Risk (%)
Total   21/426 (4.93%)   14/377 (3.71%) 
Cardiac disorders     
Cardiac failure * 1  0/426 (0.00%)  1/377 (0.27%) 
Cardiopulmonary failure * 1  1/426 (0.23%)  0/377 (0.00%) 
General disorders     
Impaired healing * 1  0/426 (0.00%)  1/377 (0.27%) 
Necrosis * 1  1/426 (0.23%)  0/377 (0.00%) 
Hepatobiliary disorders     
Cirrhosis alcoholic * 1  0/426 (0.00%)  1/377 (0.27%) 
Infections and infestations     
Diabetic gangrene * 1  1/426 (0.23%)  0/377 (0.00%) 
Gangrene * 1  1/426 (0.23%)  3/377 (0.80%) 
Localised infection * 1  1/426 (0.23%)  1/377 (0.27%) 
Osteomyelitis * 1  1/426 (0.23%)  0/377 (0.00%) 
Pneumonia * 1  0/426 (0.00%)  1/377 (0.27%) 
Pseudomembranous colitis * 1  1/426 (0.23%)  0/377 (0.00%) 
Sepsis * 1  1/426 (0.23%)  0/377 (0.00%) 
Wound infection * 1  2/426 (0.47%)  1/377 (0.27%) 
Urosepsis * 1  1/426 (0.23%)  0/377 (0.00%) 
Rectal abscess * 1  2/426 (0.47%)  0/377 (0.00%) 
Muscle abscess * 1  0/426 (0.00%)  1/377 (0.27%) 
Abscess limb * 1  1/426 (0.23%)  0/377 (0.00%) 
Device related infection * 1  1/426 (0.23%)  0/377 (0.00%) 
Investigations     
Electrocardiogram QT prolonged * 1  2/426 (0.47%)  0/377 (0.00%) 
Blood alkaline phosphatase increased * 1  1/426 (0.23%)  0/377 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/426 (0.23%)  0/377 (0.00%) 
Hyperkalaemia * 1  1/426 (0.23%)  0/377 (0.00%) 
Musculoskeletal and connective tissue disorders     
Soft tissue necrosis * 1  1/426 (0.23%)  0/377 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  0/426 (0.00%)  1/377 (0.27%) 
Psychiatric disorders     
Depression * 1  1/426 (0.23%)  0/377 (0.00%) 
Renal and urinary disorders     
Renal failure * 1  1/426 (0.23%)  0/377 (0.00%) 
Renal failure acute * 1  1/426 (0.23%)  0/377 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/426 (0.23%)  1/377 (0.27%) 
Surgical and medical procedures     
Suture insertion * 1  1/426 (0.23%)  0/377 (0.00%) 
Skin implant * 1  0/426 (0.00%)  1/377 (0.27%) 
Vascular disorders     
Arterial thrombosis limb * 1  1/426 (0.23%)  0/377 (0.00%) 
Shock * 1  1/426 (0.23%)  0/377 (0.00%) 
Lymphorrhoea * 1  0/426 (0.00%)  1/377 (0.27%) 
Extremity necrosis * 1  0/426 (0.00%)  1/377 (0.27%) 
Peripheral arterial occlusive disease * 1  1/426 (0.23%)  0/377 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Moxifloxacin PIP/TAZ-AMC
Affected / at Risk (%) Affected / at Risk (%)
Total   35/426 (8.22%)   20/377 (5.31%) 
Gastrointestinal disorders     
Diarrhoea * 1  10/426 (2.35%)  8/377 (2.12%) 
Nausea * 1  5/426 (1.17%)  3/377 (0.80%) 
General disorders     
Pyrexia * 1  7/426 (1.64%)  3/377 (0.80%) 
Investigations     
Electrocardiogram QT prolonged * 1  1/426 (0.23%)  5/377 (1.33%) 
Nervous system disorders     
Headache * 1  5/426 (1.17%)  3/377 (0.80%) 
Vascular disorders     
Hypertension * 1  11/426 (2.58%)  2/377 (0.53%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Ten patients (six from the moxifloxacin group and 4 from the comparator group) did not receive study medication. They were excluded from the safety analyses. No adverse events were reported in these patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00402727    
Other Study ID Numbers: 11974
2006-001599-18 ( EudraCT Number )
First Submitted: November 21, 2006
First Posted: November 22, 2006
Results First Submitted: October 13, 2009
Results First Posted: January 11, 2010
Last Update Posted: November 7, 2014