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:
Theravance, Inc.
Information provided by:
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT00107978
First received: April 11, 2005
Last updated: December 10, 2010
Last verified: December 2010
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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
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 |
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| 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
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] |
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| <=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] |
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| Female | 200 | 187 | 387 |
| Male | 258 | 294 | 552 |
|
Ethnicity (NIH/OMB)
[units: participants] |
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| 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] |
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| 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] |
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| 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] |
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| Diabetic | 113 | 118 | 231 |
| Not diabetic | 345 | 363 | 708 |
Outcome Measures
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
Publications of Results:
| 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:
|
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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| No text entered. |
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
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 Publica 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, Welfare and Family Affairs 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 |