Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)

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

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