Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
Condition: Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Skin Diseases, Bacterial; Skin Diseases
Intervention: delafloxacin; delafloxacin; tigecycline
Intervention description: 300 mg intravenous every 12 hours; 450 mg intravenous every 12 hours; 100 mg then 50 mg intravenous tigecycline every 12 hours
Intervention MeSH terms: Tigecycline; Fluoroquinolones; Delafloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: complicated; skin

Summary:

      The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341
      (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in
      the treatment of complicated skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥18 years of age) men or women with cSSSI

          -  Diagnosis of one of the following 3 types of cSSSI: wound infection that has developed
             within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the
             7 days before enrollment; or cellulitis that has developed in the 7 days before
             enrollment

          -  Sexually active men and women 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

          -  The patient must be willing to comply with protocol requirements

        Exclusion Criteria:

          -  Medical history of hypersensitivity or allergic reaction to quinolones, tetracycline
             or tetracycline derivatives

          -  Chronic or underlying skin condition at the site of infection

          -  Infection involving prosthetic materials or foreign bodies (unless prosthetic material
             will be removed within 24 hours), infection associated with a human bite,
             osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis,
             necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome,
             gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired
             arterial blood supply, current evidence of deep vein thrombosis or superficial
             thrombophlebitis

          -  An infection that would normally have a high cure rate after surgical incision alone

          -  Any infection expected to require other antimicrobial agents in addition to study drug

          -  Receipt of >24 hours of systemic antibiotic therapy in the 7 days before enrollment

          -  A severely compromised immune system

          -  History of Child-Pugh Class B or C liver disease or severe renal impairment
             (creatinine clearance of <30 mL/minute)

          -  Pregnancy or lactation