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)

• ClinicalTrials.gov Identifier: NCT02452918
• Recruitment Status: Completed
• First Posted: May 25, 2015
• Last Update Posted: October 4, 2016
• Sponsor: The Medicines Company
• Information provided by (Responsible Party): The Medicines Company

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acute Bacterial Skin and Skin Structure Infection	Drug: Oritavancin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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)
• Study Start Date: June 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: oritavancin; oritavancin, a single 1200mg IV dose, over 3 hours	Drug: Oritavancin; a single 1200 mg IV dose of Orbactiv (oritavancin); Other Name: Orbactiv

Outcome Measures

Primary Outcome Measures :

1. The primary outcome is the safety of the administration of oritavancin in subjects on chronic warfarin. [ Time Frame: 2 weeks ]
   This will be assessed through a composite assessment of vital signs, laboratory abnormalities, and the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures :

1. Clinical cure as assessed by Investigator [ Time Frame: 48-72 hours after start of oritavancin dose and at Day 7 ]

   A patient is classified as "success" if all of the following are met:

   Cessation of spread or reduction of the lesion Resolution (absence) of fever (temperature less than 37.7C) No rescue antibiotic medication

   A patient cannot be classified as a "success" at 48-72 hours (i.e., patient is a failure) if:

   Death (all-cause mortality) from the start of oritavancin administration

   Fever (one or more temperature readings of greater than or equal to 37.7°C between 48 and 72 hours) Spread of lesion defined as an increase in size (length, width, or area) of the redness, edema, and/or induration such that the size of the lesion is greater than the size at baseline Administration of rescue antibacterial drug therapy or any non-trial antibacterial drug therapy for the treatment of ABSSSI prior to the 48-72 hours clinical cure evaluation Requires an additional unplanned surgical procedure after start of therapy

Other Outcome Measures:

1. Potential for antibody development following a single dose oritavancin administration [ Time Frame: Days 1, 2, 3, 7, and 14 ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, New Jersey

Somers Point, New Jersey, United States, 08244

Sponsors and Collaborators

The Medicines Company

Investigators

• Study Director: Jeff Loutit, MBChB; The Medicines Company

More Information

• Responsible Party: The Medicines Company
• ClinicalTrials.gov Identifier: NCT02452918
• Other Study ID Numbers: MDCO-ORI-14-03
• First Posted: May 25, 2015
• Last Update Posted: October 4, 2016
• Last Verified: October 2016

Keywords provided by The Medicines Company:

skin infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Skin Diseases, Bacterial; Disease Attributes; Pathologic Processes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Diseases; Oritavancin; Anti-Bacterial Agents; Anti-Infective Agents