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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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Staphylococcal Skin Infection
Interventions: Drug: Telavancin
Drug: Vancomycin

  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
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  
unknown                 5                 4  



  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
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  
Number of Participants  
[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
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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
No text entered.


  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 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:

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
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Chile: Instituto de Salud Pública de Chile
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Korea: Ministry for Health and Welfare
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Peru: Ethics Committee
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Department of Health
United Kingdom: Food Standards Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration