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 ]
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