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Safety of Either a Single or Two IV Doses of Orbactiv in Subjects With ABSSSI

Primary Purpose

Skin Diseases, Bacterial

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
oritavancin
placebo (D5W)
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Diseases, Bacterial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of ABSSSI (wound infections, Cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy
  • Able to give informed consent and willing to comply with all required study procedures

Exclusion Criteria:

  • Infections associated with, or in close proximity to, a prosthetic device
  • Severe sepsis or refractory shock
  • Known or suspected bacteremia at time of screening
  • ABSSSI due to or associated with any of the following:
  • Infections suspected or documented to be caused by Gram-negative pathogens (i.e., human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis)
  • Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens
  • Diabetic foot infections (infection extending distal to the malleoli in a subject with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot)
  • Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis)
  • Infected burns
  • A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa
  • Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
  • Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection)
  • Infections known to be caused by a Gram-positive organism with a vancomycin minimum inhibitory concentration (MIC) >2 μg/mL or clinically failing prior therapy with glycopeptides
  • Catheter site infections
  • Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted)
  • Subjects who are likely to need treatment with IV unfractionated heparin sodium within 48 hours after oritavancin administration
  • Last known cluster of differentiation 4 (CD4) count <200 cells/mm3 in subjects with known human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)
  • Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3
  • Significant or life-threatening condition (e.g., endocarditis) that would confound or interfere with the assessment of safety
  • Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control: (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are exempt from this exclusion
  • History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or dalbavancin) or any of their excipients. Note: subjects who have had histamine-like infusion reactions to a glycopeptide are not excluded
  • Subjects unwilling to forego blood and/or blood product donation for at least 1 month from initiation of oritavancin dose
  • Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study
  • Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
  • Subjects who the investigator considers unlikely to adhere to the protocol, comply with oritavancin administration, or complete the clinical study (e.g., unlikely to survive 90 days from initiation of oritavancin dosing)
  • Prior exposure to oritavancin alone or in combination with another product.

Sites / Locations

  • South Jersey Infectious Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Two doses oritavancin

One dose oritavancin, one dose placebo

Arm Description

On Day 1 of the study, subjects will be administered a single 1200-mg IV dose of oritavancin in 1000 mL D5W. On Day 7, an additional 1200-mg IV dose of oritavancin in 1000 mL D5W will be administered.

On Day 1 of the study, subjects will be administered a single 1200-mg IV dose of oritavancin in 1000 mL D5W. On Day 7, a placebo (D5W) will be administered.

Outcomes

Primary Outcome Measures

Safety: AEs/SAEs
a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing
Safety: clinical safety laboratory results
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
Safety: vital sign measurements
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline

Secondary Outcome Measures

Clinical Cure - Resolution of fever
Resolution (absence) of fever (temperature <37.7°C)
Clinical Cure - Cessation of spread or reduction of the lesion
Cessation of spread, or reduction in size (length, width, and area) such that the size of the lesion is less than or equal to the size at baseline
Clinical Cure - No rescue antibiotic medication
No rescue antibiotic medication was needed

Full Information

First Posted
October 4, 2016
Last Updated
June 28, 2017
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT02925416
Brief Title
Safety of Either a Single or Two IV Doses of Orbactiv in Subjects With ABSSSI
Official Title
A Double-Blind, Randomized Study to Evaluate the Safety of Either a Single 1200-mg Intravenous (IV) Dose of Orbactiv™ (Oritavancin) and Placebo or Two IV Doses of Orbactiv™ in Subjects Being Treated for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 20, 2017 (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
The purpose of this study is to evaluate the safety and tolerability of two 1200-mg IV infusions of oritavancin when administered one week apart.
Detailed Description
Clinical studies in adult subjects with ABSSSI have demonstrated that a single 1200-mg IV dose of oritavancin was clinically non-inferior, well tolerated, and had a similar safety profile to 7 to 10 days of IV vancomycin treatment. The 1200-mg dose of oritavancin is the United States (US) approved therapeutic dose. Subjects with ABSSSI will be enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart. The safety information will include the potential for antibody production following two 1200-mg IV infusions of oritavancin. This study will be a randomized, double-blind study. Subjects will be randomized to receive either two doses of oritavancin or one dose of oritavancin and a single dose of placebo one week apart in order to obtain safety information. This safety information will include information regarding the potential for antibody production following one or two doses of 1200 mg oritavancin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Bacterial

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two doses oritavancin
Arm Type
Experimental
Arm Description
On Day 1 of the study, subjects will be administered a single 1200-mg IV dose of oritavancin in 1000 mL D5W. On Day 7, an additional 1200-mg IV dose of oritavancin in 1000 mL D5W will be administered.
Arm Title
One dose oritavancin, one dose placebo
Arm Type
Other
Arm Description
On Day 1 of the study, subjects will be administered a single 1200-mg IV dose of oritavancin in 1000 mL D5W. On Day 7, a placebo (D5W) will be administered.
Intervention Type
Drug
Intervention Name(s)
oritavancin
Intervention Type
Drug
Intervention Name(s)
placebo (D5W)
Primary Outcome Measure Information:
Title
Safety: AEs/SAEs
Description
a composite measure of the number and types of AEs/SAEs encountered and relationship to time of dosing
Time Frame
From consent until day 21 follow up
Title
Safety: clinical safety laboratory results
Description
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
Time Frame
From consent until day 21 follow up
Title
Safety: vital sign measurements
Description
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
Time Frame
From consent until day 21 follow up
Secondary Outcome Measure Information:
Title
Clinical Cure - Resolution of fever
Description
Resolution (absence) of fever (temperature <37.7°C)
Time Frame
Determined by the investigator at Day 7
Title
Clinical Cure - Cessation of spread or reduction of the lesion
Description
Cessation of spread, or reduction in size (length, width, and area) such that the size of the lesion is less than or equal to the size at baseline
Time Frame
Determined by the investigator at Day 7
Title
Clinical Cure - No rescue antibiotic medication
Description
No rescue antibiotic medication was needed
Time Frame
Determined by the investigator at Day 7
Other Pre-specified Outcome Measures:
Title
Potential for antibody development
Description
A composite measure of multiple laboratory results (direct and indirect antiglobulin test, immunoglobulin panel assays, assay for oritavancin antibodies) assessing the potential for antibody development following single and multiple doses of oritavancin
Time Frame
From screening (≤24 hours from 1st dose) until day 21 follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ABSSSI (wound infections, Cellulitis/erysipelas, or cutaneous abscess) suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy Able to give informed consent and willing to comply with all required study procedures Exclusion Criteria: Infections associated with, or in close proximity to, a prosthetic device Severe sepsis or refractory shock Known or suspected bacteremia at time of screening ABSSSI due to or associated with any of the following: Infections suspected or documented to be caused by Gram-negative pathogens (i.e., human or animal bites, injuries contaminated with fresh or salt water, external malignant otitis) Wound infections (surgical or traumatic) and abscesses with only Gram-negative pathogens Diabetic foot infections (infection extending distal to the malleoli in a subject with diabetes mellitus and peripheral neuropathy and/or vascular insufficiency or any ulceration of their foot) Concomitant infection at another site not including a secondary ABSSSI lesion (e.g., septic arthritis, endocarditis, osteomyelitis) Infected burns A primary infection secondary to a pre-existing skin disease with associated inflammatory changes such as atopic dermatitis, eczema, or hidradenitis suppurativa Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous) Any evolving necrotizing process (i.e., necrotizing fasciitis), gangrene, or infection suspected or proven to be caused by Clostridium species (e.g., crepitance on examination of the ABSSSI site and/or surrounding tissue(s) or radiographic evidence of subcutaneous gas in proximity to the infection) Infections known to be caused by a Gram-positive organism with a vancomycin minimum inhibitory concentration (MIC) >2 μg/mL or clinically failing prior therapy with glycopeptides Catheter site infections Currently receiving chronic systemic immunosuppressive therapy such as chemotherapy or prednisone (prednisone at non-immunosuppressive doses of ≤15 mg/day is permitted) Subjects who are likely to need treatment with IV unfractionated heparin sodium within 48 hours after oritavancin administration Last known cluster of differentiation 4 (CD4) count <200 cells/mm3 in subjects with known human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) Neutropenia with absolute neutrophil count (ANC) <500 cells/mm3 Significant or life-threatening condition (e.g., endocarditis) that would confound or interfere with the assessment of safety Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 acceptable methods of birth control: (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥2 years postmenopausal or surgically sterile are exempt from this exclusion History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or dalbavancin) or any of their excipients. Note: subjects who have had histamine-like infusion reactions to a glycopeptide are not excluded Subjects unwilling to forego blood and/or blood product donation for at least 1 month from initiation of oritavancin dose Treatment with investigational medicinal product within 30 days or 5 half-lives, whichever is longer, before enrollment and for the duration of the study Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection Subjects who the investigator considers unlikely to adhere to the protocol, comply with oritavancin administration, or complete the clinical study (e.g., unlikely to survive 90 days from initiation of oritavancin dosing) Prior exposure to oritavancin alone or in combination with another product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fusaro
Organizational Affiliation
Senior Clinical Director
Official's Role
Study Director
Facility Information:
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety of Either a Single or Two IV Doses of Orbactiv in Subjects With ABSSSI

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