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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)

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ClinicalTrials.gov Identifier: NCT00077675
Recruitment Status : Completed
First Posted : February 13, 2004
Results First Posted : January 11, 2010
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Infections, Gram-Positive Bacterial Drug: Telavancin Drug: vancomycin or antistaphylococcal penicillin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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)
Study Start Date : February 2004
Primary Completion Date : September 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
  • VIBATIV
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

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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 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

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): NCT00077675


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

Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00077675     History of Changes
Other Study ID Numbers: I6424-202b
First Posted: February 13, 2004    Key Record Dates
Results First Posted: January 11, 2010
Last Update Posted: May 18, 2010
Last Verified: May 2010

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Abscess
Burns
Cellulitis
Ulcer
Wound infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Penicillins
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents