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

Sponsor:	Theravance
Information provided by:	Theravance
ClinicalTrials.gov Identifier:	NCT00061633

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Burns Cellulitis

Drug Information available for: Telavancin Vancomycin Vancomycin hydrochloride Penicillins

U.S. FDA Resources

Further study details as provided by Theravance:

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061633

Locations

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

Sponsors and Collaborators

Theravance

Investigators

Principal Investigator:

G. Ralph Corey, MD

Duke University

More Information

No publications provided

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
Study First Received:	May 30, 2003
Results First Received:	December 2, 2009
Last Updated:	January 27, 2010
Health Authority:	South Africa: Department of Health; South Africa: Human Research Ethics Committee; South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council; United States: Food and Drug Administration

Additional relevant MeSH terms:

Abscess
Cellulitis
Ulcer
Wound Infection
Gram-Positive Bacterial Infections
Suppuration
Infection
Inflammation
Pathologic Processes

Skin Diseases, Infectious
Connective Tissue Diseases
Wounds and Injuries
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012