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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)

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

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

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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

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

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.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452918

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United States, New Jersey
Somers Point, New Jersey, United States, 08244
Sponsors and Collaborators
The Medicines Company
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Study Director: Jeff Loutit, MBChB The Medicines Company
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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT02452918    
Other Study ID Numbers: MDCO-ORI-14-03
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by The Medicines Company:
skin infection
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Bacterial
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents