Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus - Full Text View

Purpose

Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Condition	Intervention	Phase
Staphylococcal Skin Infection	Drug: Telavancin Drug: Vancomycin	Phase 3


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
Official Title:	A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus

Resource links provided by NLM:

Drug Information available for: Vancomycin Vancomycin hydrochloride Staphylococcus aureus Telavancin Telavancin hydrochloride

U.S. FDA Resources

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:

Clinical Response [ Time Frame: 7-14 days following end of antibiotic treatment ] [ Designated as safety issue: No ]
The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.


Enrollment:	862
Study Start Date:	January 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Telavancin	Drug: Telavancin Telavancin 10 mg/kg/day, IV for up to 14 days. Other Names: VIBATIV TD-6424
Active Comparator: Vancomycin	Drug: Vancomycin Vancomycin 1 Gm IV q 12 hrs for up to 14 days.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) either suspected or confirmed as the major cause of the infection:
- major abscess requiring surgical incision and drainage
- infected burn (see exclusion criteria for important qualifications)
- deep/extensive cellulitis
- infected ulcer (see exclusion criteria for important qualifications)
- wound infections
Patients must be expected to require at least 7 days of intravenous antibiotic treatment

Exclusion Criteria:

Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy prior to randomization
Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091819

Locations


United States, California
Paradise Valley Hospital, 2400 E. 4th Street
National City, California, United States, 91950

Sponsors and Collaborators

Theravance Biopharma Antibiotics, Inc.

Investigators


Principal Investigator:	G. Ralph Corey, MD	Duke University

More Information

Publications:

Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.

Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.


Responsible Party:	Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00091819 History of Changes
Other Study ID Numbers:	0017
Study First Received:	September 17, 2004
Results First Received:	November 3, 2009
Last Updated:	December 10, 2010
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council Belgium: Federal Agency for Medicines and Health Products, FAMHP Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Croatia: Agency for Medicinal Product and Medical Devices Croatia: Ethics Committee Croatia: Ministry of Health and Social Care Croatia: Ministry of Science, Education and Sports Israel: Ethics Commission Israel: Israeli Health Ministry Pharmaceutical Administration Israel: Ministry of Health Israel: The Israel National Institute for Health Policy Research and Health Services Research Malaysia: Ministry of Health Russia: Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ministry of Health of the Russian Federation Russia: Pharmacological Committee, Ministry of Health South Africa: Human Research Ethics Committee South Africa: Medicines Control Council South Africa: National Health Research Ethics Council

Keywords provided by Theravance Biopharma Antibiotics, Inc.:


staph MRSA cSSSI

Additional relevant MeSH terms:


Communicable Diseases Infection Staphylococcal Infections Staphylococcal Skin Infections Bacterial Infections Gram-Positive Bacterial Infections Skin Diseases Skin Diseases, Bacterial	Skin Diseases, Infectious Telavancin Vancomycin Anti-Bacterial Agents Anti-Infective Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS1)