A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
Condition: Skin and Subcutaneous Tissue Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Delafloxacin; Linezolid; Vancomycin
Intervention description: 300mg IV every 12 hours for 5-14 days; 600mg IV every 12 hours for 5-14 days; 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
Intervention MeSH terms: Vancomycin; Linezolid; Delafloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare clinical response to the measurement techniques of
      several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial
      Skin and Skin Structure Infection) clinical trials
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years of age) men or women

          -  Sexually active women and men with partners of childbearing potential must agree to
             use an acceptable form of contraception as determined by the investigator during
             participation in the study and for 30 days after the final dose of study drug

          -  Female partners of male subjects should also use an additional reliable method of
             contraception during study and for 30 days after the final dose of study drug

          -  Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection
             types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn
             infection

          -  Subjects must have lymph node enlargement due to the present infection or at least one
             of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC
             (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (> 5.0mg/L)

          -  In the opinion of the investigator, the subject must require and be a suitable
             candidate for IV antibiotic therapy

        Exclusion Criteria:

          -  A medical history of significant hypersensitivity or allergic reaction to quinolones,
             linezolid, vancomycin, or vancomycin derivatives

          -  Women who are pregnant or lactating

          -  Any chronic or underlying skin condition at the site of infection that may complicate
             the assessment of response

          -  Subjects with any of the following: infection involving prosthetic materials or
             foreign bodies, infection associated with a human or animal bite, osteomyelitis,
             decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing
             fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis,
             tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body
             surface area, severely impaired arterial blood supply, current evidence of deep vein
             thrombosis or superficial thrombophlebitis

          -  Minor abscesses, unless present with one of the ABSSSI types

          -  Any infection expected to require other antimicrobial agents in addition to study drug

          -  Receipt of > 24 hours of systemic antibiotic therapy in the 14 days before enrollment
             unless one of the following is documented: the subject received a single dose of a
             short-acting antibacterial drug 3 or more days before clinical trial enrollment for
             surgical prophylaxis or recently completed treatment with an antibacterial drug for an
             infection other than ABSSSI and the drug does not have antibacterial activity against
             bacterial pathogens that cause ABSSSI

          -  Receipt of more than 1 dose of a potentially effective antibacterial agent for
             treatment of the ABSSSI under study prior to enrollment

          -  Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment

          -  Severely compromised immune systems

          -  Subjects taking any medicinal product which inhibits monoamine oxidases A or B or
             within 2 weeks of Screening

          -  Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic
             blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial
             reading

          -  Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the
             following types of medications: sympathomimetic agents, vasopressive agents,
             dopaminergic agents, or other agents with the potential for serotonergic interactions

          -  Subjects with carcinoid syndrome and/or subjects taking any of the following
             medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin
             5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone

          -  Known history of liver disease

          -  History of severe renal impairment

          -  Life expectancy of < 3 months

          -  Any underlying disease that, in the opinion of the investigator, could interfere with
             the subject's ability to participate in the study

          -  Subjects previously randomized in this study or in who have received a dose of an
             investigational drug within 30 days of randomization

          -  Subjects > 140 kg in body weight