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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oritavancin | Other / unclassified | 1200 mg | Intravenous |
| Background | Warfarin | Small molecule | — | — |
Indications
No indication recorded.