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

Tracking Information

First Received Date ^ICMJE

February 10, 2004

Last Updated Date

June 23, 2005

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00077675 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 Infections of the Skin and Soft Tissue

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. This study will measure how well TD-6424 can control infections and whether the drug is safe to give 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

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

200

Completion Date

July 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

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

NCT00077675

Responsible Party

Study ID Numbers ^ICMJE

I6424-202b, FAST 2

Study Sponsor ^ICMJE

Theravance

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

G. Ralph Corey, MD

Duke University

Information Provided By

Theravance

Verification Date

August 2004

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