Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection
Condition: Skin Diseases, Bacterial
MeSH terms: Skin Diseases, Bacterial; Skin Diseases
Intervention: Oritavancin; Placebo (D5W)
Intervention description: Administered intravenously; Administered intravenously
Intervention MeSH terms: Oritavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.