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)

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 Overview

• Status: Completed
• Conditions: Acute Bacterial Skin and Skin Structure Infection
• Intervention / Treatment: Drug: Oritavancin; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somers Point, New Jersey, United States, 08244

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oritavancin 1200 mg Without Concomitant Warfarin Therapy; Oritavancin as a single 1200 mg IV dose administered over 3 hours in participants with ABSSSI who were not on concomitant warfarin therapy	Drug: Oritavancin; Administered intravenously; Other Names: Orbactiv
Experimental: Oritavancin 1200 mg With Concomitant Warfarin Therapy; 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	Drug: Oritavancin; Administered intravenously; Other Names: Orbactiv; Drug: Warfarin; Administered as a concomitant medication at a standard dose and dosing schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 weeks after first administration of oritavancin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 48 to 72 hours after start of oritavancin dose and at Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential for antibody development following a single dose oritavancin administration	This will be a composite of tests with the single outcome measure of establishing the presence or absence of antibodies, and identifying the antibodies present, if any. To provide this single outcome measure, plasma samples taken after dosing will be tested for immunoglobulins, direct and indirect Coombs, and oritavancin antibodies.	Days 1, 2, 3, 7, and 14

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Study Director: Medical Information, Melinta Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2015
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): July 5, 2016

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimated): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: skin infection
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Skin Diseases, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Anticoagulants; Warfarin; Oritavancin
• Other Study ID Numbers: MDCO-ORI-14-03