Phase 2 Trial of TD 6424 Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections

This study has been completed.

First Received: May 30, 2003 Last Updated: June 23, 2005 History of Changes

Sponsored by:	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 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: TD-6424	Phase II

MedlinePlus related topics: Burns Cellulitis

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:	100
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2003

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 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
deep/extensive cellulitis
infected ulcer
wound infections

Contacts and Locations

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

Locations

United States, Ohio
St. Rita's Medical Center
Lima, Ohio, United States, 45801

Sponsors and Collaborators

Theravance

Investigators

Principal Investigator:

G. Ralph Corey, MD

Duke University

More Information

No publications provided

Study ID Numbers:	I6424-202a, FAST
Study First Received:	May 30, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00061633 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Burns
Bacterial Infections
Skin Diseases
Ulcer
Wounds and Injuries
Disorders of Environmental Origin
Inflammation

Cellulitis
Gram-Positive Bacterial Infections
Skin Diseases, Infectious
Abscess
Connective Tissue Diseases
Suppuration
Wound Infection

Additional relevant MeSH terms:

Bacterial Infections
Communicable Diseases
Wounds and Injuries
Disorders of Environmental Origin
Infection
Inflammation
Cellulitis

Gram-Positive Bacterial Infections
Skin Diseases, Infectious
Pathologic Processes
Connective Tissue Diseases
Suppuration
Wound Infection

ClinicalTrials.gov processed this record on May 06, 2009