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Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01431339
First received: September 8, 2011
Last updated: December 27, 2013
Last verified: December 2013
Results First Received: December 27, 2013  
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: Abscess
Wound Infection
Surgical Site Infection
Cellulitis
Interventions: Drug: IV Dalbavancin
Drug: Vancomycin/Linezolid

  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
No text entered.

Reporting Groups
  Description
Dalbavancin IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Vancomycin With Possible Switch to Oral Linezolid Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days

Participant Flow:   Overall Study
    Dalbavancin     Vancomycin With Possible Switch to Oral Linezolid  
STARTED     371     368  
Safety Population     368     367  
COMPLETED     332     333  
NOT COMPLETED     39     35  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dalbavancin IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Vancomycin With Possible Switch to Oral Linezolid Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
Total Total of all reporting groups

Baseline Measures
    Dalbavancin     Vancomycin With Possible Switch to Oral Linezolid     Total  
Number of Participants  
[units: participants]
  371     368     739  
Age  
[units: years]
Mean ± Standard Deviation
  49.1  ± 16.54     51.4  ± 16.16     50.2  ± 16.38  
Gender  
[units: participants]
     
Female     148     167     315  
Male     223     201     424  



  Outcome Measures
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1.  Primary:   Early Clinical Efficacy   [ Time Frame: After 48-72 hours of therapy ]

2.  Secondary:   Clinical Status   [ Time Frame: End of Treatment Visit (Day 14-15) ]

3.  Secondary:   >= 20% Reduction in Lesion Area   [ Time Frame: 48-72 hours after the initiation of study therapy ]

4.  Secondary:   Clinical Status   [ Time Frame: Follow-Up Visit (day 28) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Michael Zelasky
Organization: Durata Therapeutics
phone: 203-871-4616
e-mail: mzelasky@duratatx.com


No publications provided by Durata Therapeutics, Inc.

Publications automatically indexed to this study:

Responsible Party: Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01431339     History of Changes
Other Study ID Numbers: DUR001-302
Study First Received: September 8, 2011
Results First Received: December 27, 2013
Last Updated: December 27, 2013
Health Authority: United States: Food and Drug Administration