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

Condition(s) targeted: Infections, Gram-Positive Bacterial

Intervention: Telavancin (Drug); vancomycin or antistaphylococcal penicillin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Theravance Biopharma Antibiotics, Inc.

Official(s) and/or principal investigator(s):
G. Ralph Corey, MD, Principal Investigator, Affiliation: Duke University

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

Starting date: February 2004
Last updated: May 13, 2010