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)

The Medicines Company

Status and phase: Completed; Phase 4

Conditions: Acute Bacterial Skin and Skin Structure Infection

Treatments: Drug: Oritavancin; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02452918

MDCO-ORI-14-03

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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* *Participants in the non-warfarin group are not required to be on chronic warfarin therapy.

Exclusion criteria

• Known or suspected bacteremia, sepsis or refractory shock
• Participants who are likely to need treatment with IV heparin within 48 hours
• Significant or life-threatening condition
• Women who are pregnant or nursing
• Receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone
• CD4 count <200 cells/mm^3 in participants with known human immunodeficiency virus or acquired immune deficiency syndrome
• Neutropenia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Oritavancin 1200 mg Without Concomitant Warfarin Therapy

Experimental group

Description:

Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy

Treatment:

Drug: Oritavancin

Oritavancin 1200 mg With Concomitant Warfarin Therapy

Experimental group

Description:

Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were on concomitant warfarin therapy at a standard dose and dosing schedule

Treatment:

Drug: Oritavancin

Drug: Warfarin