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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 4, multicenter, open-label safety study of a single 1200 mg intravenous (IV) infusion of oritavancin in adult subjects 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 patients with ABSSSI, who are not on concomitant warfarin therapy, will also be enrolled to obtain information regarding the potential for antibody production following a single dose of oritavancin administration in patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Oritavancin; Warfarin

Criteria

Inclusion Criteria:

• Diagnosis of ABSSSI (wound infection, cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy

• Must be currently being treated with chronic warfarin therapy* *Patients in the non-warfarin group are not required to be on chronic warfarin therapy.

Exclusion Criteria:

• Known or suspected bacteremia

• Subjects who are likely to need treatment with IV heparin within 48 hours

• Significant or life-threatening condition

• Women who are pregnant or nursing

• Known HIV or AIDS

• Neutropenia