Status:
TERMINATED
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Lead Sponsor:
Novartis
Conditions:
Staphylococcal Skin Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00463801
Start Date
January 1 2007
Last Update
March 24 2011
Active Locations (2)
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1
Novartis Italy
Novartis Italy, Italy
2
Novartis Italy
Saronno, Italy