Phase 3 Study of Dalbavancin for Acute Bacterial Infections of the Skin
Durata Therapeutics announced retrospective data from its Phase 3 study of dalbavancin for the treatment of acute bacterial infections of the skin. This data comes from a reanalysis of a previous study. According to the original study protocols, patients with complicated skin and skin structure infections (SSSI), including infections known or suspected to involve methicillin-resistant Staphylococcus aureus (MRSA), were randomized in a 2:1 ratio, double-blind manner to receive dalbavancin 1000mg given intravenously on Day 1 and 500mg IV on Day 8 or linezolid 600mg IV or IV/orally every 12 hours for 14 days.
The primary efficacy endpoint was assessed by determining clinical and microbiological responses at the test-of-cure visit at 28 days following initiation of therapy. A successful clinical response was one in which signs and symptoms of SSSI had improved such that no further antibacterial therapy was warranted. As previously reported, the trial met the original endpoint, demonstrating non-inferiority to linezolid at 28 days. The reanalysis of the study data demonstrated that clinical efficacy associated with dalbavancin was again similar to linezolid, based on both resolution of fever and cessation of spread of the lesion within a 48- to 96-hour period after the start of therapy. Recently, the FDA issued new draft guidance establishing that antibiotic effectiveness be assessed between 48 and 72 hours following initiation of therapy.
Dalbavancin is a long-acting, intravenous lipoglycopeptide.
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