Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
Condition: Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Intervention: Daptomycin; Vancomycin or Semi-Synthetic Penicillins (SSPs)
Intervention description: Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.; Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.
Intervention MeSH terms: Vancomycin; Penicillins; Daptomycin; Floxacillin; Cloxacillin; Oxacillin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Skin infection; Daptomycin; Elderly; Gram positive; Complicated skin and soft tissue infections

Summary:

      The purpose of this study is to provide data documenting the efficacy of daptomycin in
      elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
    

Eligibility criteria:

        Inclusion criteria:

        Patients 65 years or older with infection of sufficient severity to require in-patient
        hospitalization, with parenteral antimicrobial therapy for at least 96 hours.

        Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections
        (cSSTIs) with or without bacteremia:

          -  Wound infections,

          -  Major abscesses with or without recognized preceding trauma, that require antibiotic
             therapy in addition to surgical incision and drainage,

          -  Severe carbunculosis,

          -  Infected ulcers (except patients with multiple infected ulcers) associated with:
             diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).

        Exclusion criteria:

        Conditions requiring surgery that in and of itself would cure the infection or remove the
        infected site (e.g., amputation).

        Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).

        Cellulitis, including erysipelas, not associated with complicating factors. However,
        patients with cellulitis associated with more serious infection (e.g., surgical wound,
        diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited
        to 30%).

        Infections for which outcome is difficult to assess:

          -  Perirectal abscess,

          -  Hidradenitis suppurativa,

          -  Gangrene,

          -  Infected human or animal bites,

          -  Multiple infected ulcers at distant sites,

          -  Infected burns (only third degree burn wound or wound area of more than 10 cm
             diameter),

          -  Conditions requiring emergency surgery including necrotizing fasciitis.

        Medical conditions:

          -  History of significant allergy or intolerance to Vancomycin or Daptomycin.
             Hypersensitivity to SSPs penicillins is not an exclusion criterion,

          -  Concomitant clinically suspected or confirmed other site of infection or disorder at
             study entry that may interfere with the evaluation in this protocol,

          -  Infections associated with a permanent prosthetic device that will not be removed
             within 24 hours after enrolment,

          -  Known or suspected HIV infection with a CD4+ T-cell count < 500/μL (HIV testing is not
             required),

          -  Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST > 5 times ULN and/ or
             total bilirubin > 2 times ULN at screening,

          -  Calculated creatinine clearance by the Cockcroft-Gault equation using actual body
             weight < 30 mL/min or any type of dialysis,

          -  Treatment with any investigational agent or device within 30 days of study drug
             administration.

        Exclusion criteria related to medications:

          -  Previous systemic antibacterial therapy for the treatment of Gram-positive complicated
             skin and soft tissue infections for more than 24 hours within 48 hours prior to the
             day of first infusion of study drug unless:

          -  The previous antibacterial therapy was administered for 3 or more calendar days with
             either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and
             was not Vancomycin or SSPs.

        Other protocol-defined inclusion/exclusion criteria applied.