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Study Results
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Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
This study has been terminated.
( Because of inadequate accrual. )
Study NCT00463801   Information provided by Novartis

First Received on April 19, 2007.   Last Updated on March 22, 2011   History of Changes
Results First Received: December 9, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Staphylococcal Skin Infections
Intervention: Drug: Daptomycin

  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
Daptomycin Intravenous 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.

Participant Flow:   Overall Study
    Daptomycin Intravenous  
STARTED     52  
COMPLETED     39  
NOT COMPLETED     13  
Protocol Violation                 1  
Lack of Efficacy                 2  
Adverse Event                 4  
Lost to Follow-up                 5  
No longer require therapy                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Daptomycin Intravenous 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.

Baseline Measures
    Daptomycin Intravenous  
Number of Participants  
[units: participants]
 		  52  
Age, Customized  
[units: participants]
 		 
Age 27-88 years     52  
Gender  
[units: participants]
 		 
Female     22  
Male     30  



  Outcome Measures

1.  Primary:   Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start   [ Time Frame: at Day 7 and 14 ]
  Show Outcome Measure 1

2.  Secondary:   Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria   [ Time Frame: At day 4, 7, 10 and 14 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10   [ Time Frame: At day 4 and 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous   [ Time Frame: At day 14 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Efficacy Assessed by Time of Resolution of Infection   [ Time Frame: At day 14 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE   [ Time Frame: At day 14 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)   [ Time Frame: at day 14 and follow up day i.e. day 30 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
Inadequate accrual caused the premature study termination and the insufficient sample size, therefore none of the planned study analyses were performed; nor were any tabulations with descriptive statistics were provided.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00463801     History of Changes
Other Study ID Numbers: CCBC134AIT01
Study First Received: April 19, 2007
Results First Received: December 9, 2010
Last Updated: March 22, 2011
Health Authority: Italy: The Italian Medicines Agency





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