Status and phase
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About
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.
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Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria:
Patients:
with a condition which would prevent performing protocol safety and efficacy assessments.
who have received antibiotics for more than 24 hours within the last 3 days.
with an infection involving deep tissues or unlikely to be caused by gram positive bacteria
who are nursing and will not stop nursing for at least 6 months
with a prior allergic reaction to glycopeptides (e.g. vancomycin)
with any of the following:
Primary purpose
Allocation
Interventional model
Masking
294 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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