Back to resultsA 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)
Primary Purpose
Acute Bacterial Skin and Skin Structure Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oritavancin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infection focused on measuring skin infection
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
oritavancin
Arm Description
oritavancin, a single 1200mg IV dose, over 3 hours
Outcomes
Primary Outcome Measures
The primary outcome is the safety of the administration of oritavancin in subjects on chronic warfarin.
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
Clinical cure as assessed by Investigator
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02452918
Brief Title
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)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infection
Keywords
skin infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oritavancin
Arm Type
Experimental
Arm Description
oritavancin, a single 1200mg IV dose, over 3 hours
Intervention Type
Drug
Intervention Name(s)
Oritavancin
Other Intervention Name(s)
Orbactiv
Intervention Description
a single 1200 mg IV dose of Orbactiv (oritavancin)
Primary Outcome Measure Information:
Title
The primary outcome is the safety of the administration of oritavancin in subjects on chronic warfarin.
Description
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)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Clinical cure as assessed by Investigator
Description
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
Time Frame
48-72 hours after start of oritavancin dose and at Day 7
Other Pre-specified Outcome Measures:
Title
Potential for antibody development following a single dose oritavancin administration
Description
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.
Time Frame
Days 1, 2, 3, 7, and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Loutit, MBChB
Organizational Affiliation
The Medicines Company
Official's Role
Study Director
Facility Information:
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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