TD-1792 in Gram-Positive Complicated Skin and Skin Structure Infection

This study has been completed.

Sponsored by:	Theravance
Information provided by:	Theravance
ClinicalTrials.gov Identifier:	NCT00442832

Purpose

The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.

Condition	Intervention	Phase
Complicated Skin and Skin Structure Infection	Drug: TD-1792	Phase II

Drug Information available for: Vancomycin Vancomycin hydrochloride

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, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections

Further study details as provided by Theravance:

Primary Outcome Measures:

Clinical response

Estimated Enrollment:	200
Study Start Date:	December 2006
Study Completion Date:	May 2007

Detailed Description:

TD-1792 is compared to vancomycin for the treatment of cSSSI.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
requires at least 7 days of intravenous antibiotic treatment

Exclusion Criteria:

more than 24 hours of antibiotic therapy
moderate or severe liver disease
severely neutropenic
baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442832

Locations

United States, California
Allan Churukian
National City, California, United States, 91950

Sponsors and Collaborators

Theravance

Investigators

Study Director:

Steve Barriere, PharmD

Theravance

More Information

Study ID Numbers:	0041
Study First Received:	February 28, 2007
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00442832
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theravance:

cSSSI

Study placed in the following topic categories:

Vancomycin

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009