Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection

Skin Diseases, Bacterial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925416
• Other study ID #: MDCO-ORI-16-02
• Status: Completed
• Phase: Phase 4
• Start date: January 24, 2017
• Est. completion date: June 20, 2017

Study information

• Verified date: January 2024
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the safety and tolerability of two 1200 milligram (mg) intravenous (IV) infusions of oritavancin when administered one week apart.

Description:

Clinical studies in adult participants with acute bacterial skin and skin structure infection (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 approved therapeutic dose.

Participants with ABSSSI were enrolled in this study to obtain safety information of two 1200-mg IV infusions of oritavancin when administered one week apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 participant 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)

• Participants 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/mm^3 in participants with known human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)

• Neutropenia with absolute neutrophil count (ANC) <500 cells/mm^3

• 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: participants who have had histamine-like infusion reactions to a glycopeptide are not excluded

• Participants 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

• Participants 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.

Related Conditions & MeSH terms

• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Drug:
• Oritavancin
Administered intravenously
• Placebo (D5W)
Administered intravenously

Locations

Country	Name	City	State
United States	South Jersey Infectious Disease	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Treatment emergent adverse events (TEAE) were AEs which occurred or whose severities worsened on or after the initiation of study drug. 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 Day 21 after first administration of oritavancin
Secondary	Number of Participants With a Clinical Response of Cure	Participants were classified by investigator assessment as "success" for clinical response of cure if there was a complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics was needed.	Up to Day 8 after first administration of oritavancin