Clinical Trial: A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

Brief Summary: Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Detailed Summary: This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.
Sponsor: Trius Therapeutics LLC

Current Primary Outcome: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24-31 days ]

Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Trius Therapeutics LLC

Dates:
Date Received: January 24, 2012
Date Started: February 1, 2012
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017