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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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00402727
First received: November 21, 2006
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
Results First Received: October 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Abscess
Wound Infection
Diabetic Foot
Ulcer
Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Moxifloxacin     PIP/TAZ-AMC  
STARTED     432     381  
Achieving End Of Treatment (EOT)     408     355  
Achieving Test Of Cure (TOC)     390     347  
COMPLETED     390     347  
NOT COMPLETED     42     34  
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  



  Baseline Characteristics
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Moxifloxacin     PIP/TAZ-AMC     Total  
Number of Participants  
[units: participants]
 		  432     381     813  
Age  
[units: years]
Mean ± Standard Deviation 		  53  ± 16     54  ± 16     53  ± 16  
Gender  
[units: participants]
 		     
Female     161     123     284  
Male     271     258     529  
Primary diagnosis  
[units: 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  



  Outcome Measures
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1.  Primary:   Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population   [ Time Frame: 14 - 28 days after last dose of study medication ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population   [ Time Frame: 14 - 28 days after last dose of study medication ]
  Show Outcome Measure 2

3.  Secondary:   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   [ Time Frame: 3 - 5 days after start of treatment ]
  Show Outcome Measure 3

4.  Secondary:   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   [ Time Frame: 3 - 5 days after start of treatment ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population   [ Time Frame: after 7 - 21 days of treatment ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population   [ Time Frame: after 7 - 21 days of treatment ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms   [ Time Frame: 3 - 5 days after start of treatment ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population   [ Time Frame: 3 - 5 days after start of treatment ]
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9.  Secondary:   Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the ITT Population With Causative Organisms   [ Time Frame: after 7 - 21 days of treatment ]
  Show Outcome Measure 9

10.  Secondary:   Percentage of Participants With Bacteriological Success (BS) After 7 – 21 Days of Treatment in the Microbiological Valid (MBV) Population   [ Time Frame: after 7 - 21 days of treatment ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms   [ Time Frame: 14 - 28 days after last dose of study medication ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Participants With Bacteriological Success (BS) After 14 – 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population   [ Time Frame: 14 - 28 days after last dose of study medication ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00402727     History of Changes
Other Study ID Numbers: 11974, 2006-001599-18
Study First Received: November 21, 2006
Results First Received: October 13, 2009
Last Updated: April 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices