Wounds and Injuries Clinical Trial
Official title:
Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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