Clinical trial NCT02925416: Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Bacterial
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

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 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 21 after first administration of oritavancin
Secondary outcomes:
measure: Number of Participants With a Clinical Response of Cure
timeFrame: Up to Day 8 after first administration of oritavancin
Other outcomes:
Locations:
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Medical Information
role: STUDY_DIRECTOR
References: