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:	NCT00077675

Purpose

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	Intervention	Phase
Infections, Gram-Positive Bacterial	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, 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:

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 to 14 days following completion of antibiotic treatment ] [ Designated as safety issue: Yes ]
- 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.

Enrollment:	201
Study Start Date:	February 2004
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077675

Locations

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

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:	NCT00077675 History of Changes
Other Study ID Numbers:	I6424-202b
Study First Received:	February 10, 2004
Results First Received:	December 2, 2009
Last Updated:	May 13, 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

Keywords provided by Theravance:

Abscess
Burns
Cellulitis
Ulcer
Wound infections

Additional relevant MeSH terms:

Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012