Phase 2 Trial of TD-6424 Versus Standard Therapy for Complicated Gram Positive Infections of the Skin and Soft Tissue

This study has been completed.

First Received: February 10, 2004 Last Updated: June 23, 2005 History of Changes

Sponsored by:	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 can control infections and whether the drug is safe to give to patients.

Condition	Intervention	Phase
Infections, Gram-Positive Bacterial	Drug: TD-6424	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Double Blind, Multinational Trial of Intravenous TD 6424 Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections

Resource links provided by NLM:

Drug Information available for: Telavancin

U.S. FDA Resources

Further study details as provided by Theravance:

Estimated Enrollment:	200
Study Start Date:	February 2004
Estimated Study Completion Date:	July 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
deep/extensive cellulitis
infected ulcer
wound infection

Contacts and Locations

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

Locations

United States, California
Paradise Valley Hospital
National City, California, United States, 91950

Sponsors and Collaborators

Theravance

Investigators

Principal Investigator:

G. Ralph Corey, MD

Duke University

More Information

No publications provided

Study ID Numbers:	I6424-202b, FAST 2
Study First Received:	February 10, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00077675 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theravance:

Abscess
Burns
Cellulitis
Ulcer
Wound infections

Study placed in the following topic categories:

Bacterial Infections
Burns
Gram-Positive Bacterial Infections
Cellulitis

Ulcer
Abscess
Wound Infection

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Gram-Positive Bacterial Infections
Infection

ClinicalTrials.gov processed this record on July 02, 2009