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 Company17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Bacterial Skin and Skin Structure Infection

Interventions

Oritavancin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment, including abnormal vital signs or laboratory assessments. An SAE was defined as any untoward medical occurrence that at any dose resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Time frame: Up to 2 weeks after first administration of oritavancin

Secondary Outcomes

Number of Participants With a Clinical Response of Cure

Participants were classified by investigator assessment as "success" for clinical response of cure if all of the following were met: cessation of spread or reduction of the lesion; resolution (absence) of fever (temperature less than 37.7° Celsius); no rescue antibiotic medication; complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.

Time frame: At 48 to 72 hours after start of oritavancin dose and at Day 7