We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061633
Recruitment Status : Completed
First Posted : June 2, 2003
Results First Posted : January 11, 2010
Last Update Posted : January 16, 2019
Information provided by:
Cumberland Pharmaceuticals

Brief Summary:
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

Condition or disease Intervention/treatment Phase
Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections Drug: Telavancin Drug: Vancomycin or antistaphylococcal penicillin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : June 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telavancin Drug: Telavancin
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Other Names:
  • TD-6424

Active Comparator: Standard of care for cSSSI
cSSSI - complicated 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.

Primary Outcome Measures :
  1. Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population [ Time Frame: 7-14 days following end 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 the Test-of-Cure (TOC) visit.
    • Indeterminate: Inability to determine outcome.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism 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 4 days of intravenous 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 medication 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061633

Layout table for location information
United States, California
eStudy Site, 3450 Bonita Road, Ste 201
Chula Vista, California, United States, 91910
Sponsors and Collaborators
Cumberland Pharmaceuticals
Layout table for investigator information
Principal Investigator: G. Ralph Corey, MD Duke University
Layout table for additonal information
Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00061633    
Other Study ID Numbers: I6424-202a
First Posted: June 2, 2003    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: January 16, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Wound Infection
Gram-Positive Bacterial Infections
Disease Attributes
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Anti-Bacterial Agents
Anti-Infective Agents