RCT: Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections (ESTABLISH-1)

Source: JAMA Area: News Tedizolid phosphate is a novel oral, once daily oxazolidinone currently in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). The ESTABLISH-1 (Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs 10-day Oral Linezolid Therapy) study is a phase III non-inferiority study that compared tedizolid phosphate and linezolid (an oxazolidinone licensed for complicated skin and skin structure infections).   The double-blind study randomised 667 adult patients recruited from 81 study centres in North America, Latin America, and Europe to tedizolid phosphate (n = 332; 200mg once daily) for six days or linezolid (n = 335; 600mg every 12 hours) for ten days .   The primary efficacy outcome was early clinical response at the 48- to 72-hour assessment (no increase in lesion surface area from baseline and oral temperature of ?37.6°C, confirmed by a second temperature measurement within 24 ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news