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

This study has been completed.

Sponsored by: Theravance
Information provided by: Theravance

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 Treatment or Intervention Phase
Infections, Gram-Positive Bacterial
Abscess
Burns
Cellulitis
Ulcer
Wound Infections
 Drug: TD-6424
Phase II

MedlinePlus related topics:  Abscesses;   Bacterial Infections;   Burns;   Cellulitis

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: 

Expected Total Enrollment:  100

Study start: May 2003;  Study completion: December 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Location Information


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

Study chairs or principal investigators

G. Ralph Corey, MD,  Principal Investigator,  Duke University   

More Information

Study ID Numbers:  I6424-202a; FAST
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  May 30, 2003
ClinicalTrials.gov Identifier:  NCT00061633
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources