This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)

This study has been completed.
Sponsor:
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00107978
First received: April 11, 2005
Last updated: December 10, 2010
Last verified: December 2010
Results First Received: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Staphylococcal Skin Infection
Interventions: Drug: Telavancin
Drug: Vancomycin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period: 18 February 2005 to 31 May 2006

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
Telavancin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.

Participant Flow:   Overall Study
    Telavancin   Vancomycin
STARTED   458   481 
COMPLETED   425   431 
NOT COMPLETED   33   50 
Adverse Event                1                5 
Death                3                3 
Lost to Follow-up                20                28 
Withdrawal by Subject                4                9 
Protocol Violation                0                1 
Other                5                4 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Telavancin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
Total Total of all reporting groups

Baseline Measures
   Telavancin   Vancomycin   Total 
Overall Participants Analyzed 
[Units: Participants]
 458   481   939 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   377   379   756 
>=65 years   81   102   183 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.2  (16.1)   49.9  (17.0)   49.5  (16.6) 
Gender 
[Units: Participants]
     
Female   200   187   387 
Male   258   294   552 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   79   84   163 
Not Hispanic or Latino   379   397   776 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   7   9   16 
Asian   38   44   82 
Native Hawaiian or Other Pacific Islander   4   8   12 
Black or African American   69   74   143 
White   336   343   679 
More than one race   4   3   7 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   287   310   597 
South Africa   6   6   12 
Argentina   35   33   68 
Canada   35   29   64 
Chile   1   2   3 
France   0   2   2 
Germany   0   4   4 
Italy   2   1   3 
Korea, Republic of   14   16   30 
Lithuania   12   6   18 
Peru   4   1   5 
Poland   38   43   81 
Spain   2   3   5 
Taiwan   20   25   45 
United Kingdom   2   0   2 
Diabetes Status 
[Units: Participants]
     
Diabetic   113   118   231 
Not diabetic   345   363   708 


  Outcome Measures

1.  Primary:   Clinical Response   [ Time Frame: 7 to 14 days after the last antibiotic dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance, Inc
phone: 650-808-6132
e-mail: sbarriere@theravance.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00107978     History of Changes
Other Study ID Numbers: 0018
Study First Received: April 11, 2005
Results First Received: November 3, 2009
Last Updated: December 10, 2010