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

Tracking Information

First Received Date ^ICMJE

May 30, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00061633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Infections, Gram-Positive Bacterial
Abscess
Burns
Cellulitis
Ulcer
Wound Infections

Intervention ^ICMJE

Drug: TD-6424

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00061633

Responsible Party

Study ID Numbers ^ICMJE

I6424-202a, FAST

Study Sponsor ^ICMJE

Theravance

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

G. Ralph Corey, MD

Duke University

Information Provided By

Theravance

Verification Date

January 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP