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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) (FAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061633
First Posted: June 2, 2003
Last Update Posted: February 2, 2010
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.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
  Purpose
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 Intervention Phase
Infections, Gram-Positive Bacterial Abscess Burns Cellulitis Ulcer Wound Infections Drug: Telavancin Drug: Vancomycin or antistaphylococcal penicillin Phase 2

Study Type: Interventional
Study Design: 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)

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: 7-14 days following end of antibiotic treatment ]

Enrollment: 169
Study Start Date: June 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telavancin Drug: Telavancin
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Other Names:
  • VIBATIV
  • 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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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


Locations
United States, California
eStudy Site, 3450 Bonita Road, Ste 201
Chula Vista, California, United States, 91910
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
Principal Investigator: G. Ralph Corey, MD Duke University
  More Information

Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00061633     History of Changes
Other Study ID Numbers: I6424-202a
First Submitted: May 30, 2003
First Posted: June 2, 2003
Results First Submitted: December 2, 2009
Results First Posted: January 11, 2010
Last Update Posted: February 2, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Cellulitis
Gram-Positive Bacterial Infections
Wounds and Injuries
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Bacterial Infections
Vancomycin
Penicillins
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents