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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)

Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections, Gram-Positive Bacterial; Abscess; Burns; Cellulitis; Ulcer; Wound Infections

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. 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.

Clinical Details

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, Caregiver, 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.


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.

Locations and Contacts

eStudy Site, 3450 Bonita Road, Ste 201, Chula Vista, California 91910, United States
Additional Information

Starting date: June 2003
Last updated: January 27, 2010

Page last updated: August 23, 2015

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