The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
300 mg intravenous every 12 hours
450 mg intravenous every 12 hours
100 mg then 50 mg intravenous tigecycline every 12 hours
Physician Alliance Research Center
Anaheim, California, United States
Quality of Life Medical Center, LLC
Hawaiian Gardens, California, United States
Tri City Medical Center
Oceanside, California, United States
Clinical Response at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Time frame: 14-21 days after the last dose of study drug
Clinical Response in Patients With Methicillin-resistant Staphylococcus Aureus (MRSA)
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Time frame: 14-21 days after the last dose of study drug
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Crest Clinical Trials
Santa Ana, California, United States
Internal Medicine Associates of Lee County
Fort Myers, Florida, United States
Joseph M. Still Research Foundation, Inc.
Augusta, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Southeast Regional Research Group
Ludowici, Georgia, United States
Southeast Regional Research Group
Savannah, Georgia, United States
St. James Health Care
Butte, Montana, United States
...and 4 more locations