A Phase 2 interventional study of oritavancin in Staphylococcal Skin Infections, Wounds and Injuries and Abscess, sponsored by Targanta Therapeutics Corporation. Completed at 66 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-14.
Sponsored by Targanta Therapeutics Corporation · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 294 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Targanta Therapeutics Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients:
with any of the following:
Drug: oritavancin
Drug: oritavancin
Drug: oritavancin
Oritavancin as a single, infrequent or daily dose.
Clinical success at follow-up
Time frame: six months
To evaluate safety of dosing regimens.
Time frame: six months
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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