Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Condition: Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Skin Diseases, Bacterial; Staphylococcal Skin Infections
Intervention: Daptomycin
Intervention MeSH terms: Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis; Complicated skin and skin-structure infections

Summary:

      This study will evaluate the safety and efficacy of daptomycin against complicated skin and
      skin-structure infections in adults
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI)
             defined as infection normally requiring surgical/local debridement of sufficient
             severity to warrant hospitalization and intravenous antimicrobial treatment

          -  Infection to be due to Gram-positive bacteria

          -  Hospitalized subjects

          -  Written informed consent

          -  Female patients of childbearing potential must have a negative pregnancy test urine or
             serum at baseline and must use effective contraception throughout the study period.

        Exclusion criteria:

          -  Complicated skin and skin-structure infections of the following categories:

          -  Infected burns

          -  Severely impaired arterial blood supply

          -  Decubitus ulcers

          -  Infected diabetic foot ulcers associated with osteomyelitis

          -  Infected human or animal bites

          -  Perirectal abscess

          -  Necrotising fasciitis or gangrene

          -  Infections expected to require more than 14 days of intravenous antimicrobial therapy

          -  Skin and/or skin structure infection that can be treated by surgery alone

          -  Infections associated with a permanent prosthetic device that will not be removed
             within 2 days of study enrollment

          -  Uncomplicated skin or soft tissue infection

          -  Documented bacteremia at baseline

          -  Concomitant infection nearby the site of infection at baseline, potentially
             interfering with the evaluations

          -  Hospitalization for conditions related to rhabdomyolysis

          -  Human immunodeficiency virus (HIV) with cluster of differentiation (CD) < 200 or < 14%

          -  Immune function alterations

          -  Lack of sufficient purulent material for culture and Gram test

          -  Systemic or local antibiotic administration with known anti-Gram positive activity in
             the preceding 48 hours

          -  Complicated skin and soft tissue infections (cSSTI) known or believed to be related to
             fungal, parasitic or viral infection

          -  Pneumonia

          -  Local or systemic known or suspected allergy to daptomycin

          -  Creatinine clearance < 30 mL/min

          -  Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or
             Aspartate aminotransferase (AST) > 3 x Upper limit of normal (ULN) and/or bilirubin >
             1.5 x ULN

          -  Use of any experimental drugs in the preceding 30 days

          -  Severe medical conditions that in the investigator's opinion could counter indicate
             participation in the study