Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: Delafloxacin; Vancomycin; Linezolid; Piperacillin/Tazobactam; Tigecycline
Intervention description: Powder for solution for infusion 300 mg or tablet 450 mg, BID, for 5 to 14 days; Powder for solution for infusion 15mg/kg, BID, for 5 to 14 days; Solution for infusion or tablet, 600 mg BID, for 5 to 14 days; Powder for solution for infusion 4/0.5 g, TID, for 5 to 14 days; Powder for solution for infusion 50 mg, TID, for 5 to 14 days
Intervention MeSH terms: Vancomycin; Tazobactam; Linezolid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tigecycline; Delafloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will compare delafloxacin against best available therapy selected by the investigator for the cardiothoracic/leg related or abdominal site infection
Masking: Single (Outcomes Assessor)
Masking description: Only the blinded observer will be unaware of the treatment assigned to patient.
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Infection, Surgical Infection

Summary:

      The purpose of this study is to assess the efficacy and safety of delafloxacin administered
      as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with
      superficial or deep incisional surgical site infection following a cardiothoracic/related leg
      or abdominal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged more than 18 years.

          -  Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred
             within 30 days and no implant is left in place, and a diagnosis of superficial or deep
             SSI according to the CDC definition.

          -  The severity of infection requires an IV treatment and patient hospitalization
             according to the Investigator's judgment.

        Exclusion Criteria:

          -  Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to
             first dose.

          -  Any infection expected to require systemic antimicrobial agents other than study
             treatment(s).

          -  Medical history of significant hypersensitivity or allergic reaction or
             contraindication to the study drugs

          -  Medical history of central nervous system (CNS) disorders

          -  Medical history of myasthenia gravis.

          -  Medical history of C. difficile diarrhea.

          -  Organ-space infection.

          -  Complicated Intra-Abdominal Infection (cIAI)

          -  Chronic or underlying conditions at site of infection that may complicate the
             assessment of clinical response or would interfere with SSI healing.

          -  Underlying disease leading to deep immunosuppressive status.

          -  End-stage renal disease, CrCl <15 mL/min.