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)

An Open-Label Study to Evaluate the Safety of a Single 1200 mg IV Dose of Orbactiv (Oritavancin) in Subjects on Concomitant Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Bacterial Skin and Skin Structure Infection

Interventions

Type	Name	Description
DRUG	Oritavancin	Administered intravenously
DRUG	Warfarin	Administered as a concomitant medication at a standard dose and dosing schedule

Timeline

• Start date: 2015-09-29
• Primary completion: 2016-07-05
• Completion: 2016-07-05
• First posted: 2015-05-25
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

1 site across 1 country: United States