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Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

This study has been completed.
Sponsor:
Information provided by:
Rib-X Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00719810
First received: July 18, 2008
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
Results First Received: January 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Skin Structure Infections
Bacterial Skin Diseases
Staphylococcal Skin Infections
Interventions: Drug: delafloxacin
Drug: tigecycline

  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
This study targeted participants with complicated skin and skin structure infections (cSSSI), i.e. infections involving subcutaneous tissues or requiring surgical intervention. Patients could have one of three infection types: wound infection, abscess, or cellulitis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Delafloxacin 350 mg IV q12h No text entered.
Delafloxacin 450 mg IV q12h No text entered.
Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h No text entered.

Participant Flow:   Overall Study
    Delafloxacin 350 mg IV q12h     Delafloxacin 450 mg IV q12h     Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h  
STARTED     49     51     50  
COMPLETED     46     47     42  
NOT COMPLETED     3     4     8  
Adverse Event                 0                 2                 3  
Lost to Follow-up                 2                 0                 3  
Physician Decision                 0                 1                 0  
Withdrawal by Subject                 1                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Delafloxacin 350 mg IV q12h No text entered.
Delafloxacin 450 mg IV q12h No text entered.
Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h No text entered.
Total Total of all reporting groups

Baseline Measures
    Delafloxacin 350 mg IV q12h     Delafloxacin 450 mg IV q12h     Tigecycline 100 mg IV x 1, Followed by 50 mg IV q12h     Total  
Number of Participants  
[units: participants]
 		  49     51     50     150  
Age  
[units: years]
Mean ± Standard Deviation 		  42.7  ± 15.10     37.2  ± 14.35     40.4  ± 13.83     40.1  ± 14.51  
Gender  
[units: participants]
 		       
Female     18     15     15     48  
Male     31     36     35     102  



  Outcome Measures
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1.  Primary:   Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population   [ Time Frame: 14-21 days after the last dose of study drug ]
  Show Outcome Measure 1

2.  Secondary:   Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)   [ Time Frame: 14-21 days after the last dose of study drug ]
  Show Outcome Measure 2


  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
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Results Point of Contact:  
Name/Title: Eric Burak, PhD
Organization: Rib-X Pharmaceuticals, Inc
phone: 203-848-6923
e-mail: eburak@rib-x.com


No publications provided


Responsible Party: Jeanne Breen, MD, Rib-X Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00719810     History of Changes
Other Study ID Numbers: RX-3341-201
Study First Received: July 18, 2008
Results First Received: January 7, 2010
Last Updated: April 20, 2011
Health Authority: United States: Food and Drug Administration