Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients
Condition: Acute Bacterial Skin and Skin Structure Infection
MeSH terms: Skin Diseases, Bacterial
Intervention: Current Formulation of Oritavancin; Kimyrsa
Intervention description: Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W); New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)
Intervention MeSH terms: Oritavancin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa
      versus the approved oritavancin formulation in subjects with acute bacterial skin and skin
      structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and
      reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of
      oritavancin
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects may be included in the study if they meet all of the following criteria:

          1. Subject must be 18 years of age or older, male or female, and of any race.

          2. Subject must give written informed consent before initiation of any study-related
             procedures.

          3. Diagnosis of ABSSSI (wound infections, cellulitis/erysipelas, or cutaneous abscess)
             suspected or confirmed to be caused by a Gram-positive pathogen requiring IV therapy.

          4. If female, the subject is surgically sterile, postmenopausal, or, if of childbearing
             potential, agrees to use at least 2 highly effective methods of birth control (e.g.
             prescription oral contraceptives, contraceptive injections, contraceptive patch,
             intrauterine device, barrier methods, abstinence) for the duration of the study until
             60 days after study drug administration, or male partner sterilization alone.

          5. Subject must express a commitment to comply with all study visits, procedures and
             requirements for the duration of the study.

        Exclusion Criteria

        Subjects will be excluded from the study if any of the following exclusion criteria apply
        prior to randomization:

          1. Infections associated with, or in close proximity to, a prosthetic device.

          2. Severe sepsis or refractory shock.

          3. Known or suspected bacteremia at time of screening.

          4. ABSSSI due to or associated with any of the following:

               1. Infections suspected or documented to be caused by only Gram-negative pathogens
                  (i.e., infections acquired during prolonged admission in hospital or long-term
                  care facilities).

               2. 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).

               3. Concomitant infection at another site not including a secondary ABSSSI lesion
                  (e.g., septic arthritis, endocarditis, osteomyelitis).

               4. Infected burns.

               5. A primary infection secondary to a pre-existing skin disease with associated
                  inflammatory changes such as atopic dermatitis, eczema, or hidradenitis
                  suppurativa.

               6. Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular
                  disease (arterial or venous).

               7. 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).

               8. Infections known to be caused by an organism resistant to oritavancin.

               9. Catheter site infections.

          5. Treatment with investigational medicinal product within 30 days or 5 half-lives,
             whichever is longer, before enrollment and for the duration of the study.

          6. Subjects currently receiving anticoagulant therapy.

          7. Known liver function tests (LFTs) ≥ 3 times the upper limit of normal (ULN) or total
             bilirubin ≥ 2 times ULN.

          8. Any medical condition, which in the judgment of the Investigator, might interfere with
             the pharmacokinetics, distribution, metabolism, or excretion of the study drug.

          9. Any planned, major surgical procedure during the study period (Day 15).

         10. Subject is the Investigator or his/her deputy, research assistant, pharmacist, study
             coordinator, other staff or relative thereof directly involved in the conduct of the
             study.

         11. Known hypersensitivity to oritavancin, glycopeptides or HPβCD.

         12. Female subject who has a positive pregnancy test or is breastfeeding.

         13. Previous use of oritavancin or anticipated need to use a long acting glycopeptide
             during the study.