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
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.
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
Eligibility
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 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
|