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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
573
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Early Clinical Efficacy
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
Time frame: 48-72 hours after the initiation of study therapy
>= 20% Reduction in Lesion Area
Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size
Time frame: 48-72 hours after the initiation of study therapy
Clinical Status
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 non-study antibiotics
Time frame: End of Treatment Visit (Day 14-15)
Clinical Status
Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics
Time frame: Follow-Up Visit (day 28)
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Durata Study Site
Anaheim, California, United States
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Azusa, California, United States
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Bellflower, California, United States
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Buena Park, California, United States
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Carmel, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Fountain Valley, California, United States
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La Mesa, California, United States
Durata Study Site
Long Beach, California, United States
...and 81 more locations