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Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST2)

This study has been completed.
Information provided by:
Theravance Biopharma Antibiotics, Inc. Identifier:
First received: February 10, 2004
Last updated: May 13, 2010
Last verified: May 2010
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.

Condition Intervention Phase
Infections, Gram-Positive Bacterial
Drug: Telavancin
Drug: vancomycin or antistaphylococcal penicillin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram-Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7 to 14 days following completion of antibiotic treatment ]
    • Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
    • Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit
    • Indeterminate: Inability to determine outcome.

Enrollment: 201
Study Start Date: February 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin Drug: Telavancin
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
Other Names:
  • TD-6424
Active Comparator: Standard of care for cSSSI
cSSSI - comlicated skin and skin structure infections
Drug: vancomycin or antistaphylococcal penicillin
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism

    • 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 infection
  • Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Exclusion Criteria:

  • Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
  • Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, 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 identifier: NCT00077675

United States, California
Paradise Valley Hospital, 2400 E. 4th Street
National City, California, United States, 91950
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Principal Investigator: G. Ralph Corey, MD Duke University
  More Information

Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. Identifier: NCT00077675     History of Changes
Other Study ID Numbers: I6424-202b
Study First Received: February 10, 2004
Results First Received: December 2, 2009
Last Updated: May 13, 2010

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Wound infections

Additional relevant MeSH terms:
Communicable Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 28, 2017