Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.
Surgical Site Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections|
- Early Clinical Efficacy [ Time Frame: After 48-72 hours of therapy ] [ Designated as safety issue: No ]Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature
- Clinical Status [ Time Frame: End of Treatment Visit (Day 14-15) ] [ Designated as safety issue: No ]Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy
- Per-patient Microbiological Efficacy [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow up (Day 26-30) ] [ Designated as safety issue: No ]Compare the per-patient microbiological efficacy of dalbavancin to the comparator regimen.
- Efficacy by individual pathogens [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow up Visit (Day 26-30) ] [ Designated as safety issue: No ]Compare clinical efficacy by individual pathogens in the two treatment groups
- Pathogen Eradication Rates for Individual Pathogens [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow-up Visit (Day 26-30) ] [ Designated as safety issue: No ]Compare pathogen eradication rates for individual pathogens in the two treatment groups.
- Safety and Tolerability [ Time Frame: Through Long Term Follow-up Visit (Day 70) ] [ Designated as safety issue: Yes ]Safety of dalbavancin and vancomycin assessed according to the incidence of adverse events (AEs), Serious AEs and discontinuations due to AEs
- Investigator's assessment of clinical response [ Time Frame: End of Treatment Visit (Day 14-15) ] [ Designated as safety issue: No ]Success: Resolution or improvement of all signs and symptoms of the infection without treatment-related discontinuation, death or non-antibacterial intervention for the ABSSSI
|Study Start Date:||March 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
|Active Comparator: Vancomycin +/- oral linezolid||
IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
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|Study Director:||Michael Dunne, MD||Durata Therapeutics, Inc.|