Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed. The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory. SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
294
Oritavancin as a single, infrequent or daily dose.
Targanta Recruiting Site
Mobile, Alabama, United States
Targanta Recruiting Site
Anaheim, California, United States
Targanta Recruiting Site
Buena Park, California, United States
Targanta Recruiting Site
Chula Vista, California, United States
Targanta Recruiting Site
Hawaiian Gardens, California, United States
Clinical success at follow-up
Time frame: six months
To evaluate safety of dosing regimens.
Time frame: six months
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Targanta Recruiting Site
Long Beach, California, United States
Targanta Recruiting Site
Los Angeles, California, United States
Targanta Recruiting Site
Oceanside, California, United States
Targanta Recruiting Site
Rolling Hills Estates, California, United States
Targanta Recruiting Site
San Jose, California, United States
...and 56 more locations