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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Daptomycin

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