drugset / Trial / NCT02452918

A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

NCT02452918

Phase 4 Completed 17 enrolled The Medicines Company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This was a Phase 4, multicenter, open-label safety study of a single 1200 milligrams (mg) IV infusion of oritavancin in adult participants on chronic warfarin with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. An additional group of participants with ABSSSI, who were not on concomitant warfarin therapy, were also enrolled to obtain additional information following a single dose of oritavancin administration.

Timeline

Start
2015-09-29
Primary completion
2016-07-05
Completion
2016-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Oritavancin Other / unclassified 1200 mg Intravenous
Background Warfarin Small molecule

Indications

No indication recorded.