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

Drug Information available for: Telavancin

U.S. FDA Resources

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

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 May 07, 2009