TY  - JOUR
T1  - Antibiotics for skin infections: New study design and a step toward shorter course therapy
AU  - Doron S, Boucher HW
Y1  - 2013/02/13
N1  - 10.1001/jama.2013.604
JO  - JAMA
SP  - 609
EP  - 611
VL  - 309
IS  - 6
N2  - 
In this issue of JAMA, Prokocimer et al1 present the results of ESTABLISH-1 (Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs 10-day Oral Linezolid Therapy), an international, multicenter, double-blind, phase 3, noninferiority trial comparing a 6-day course of oral tedizolid phosphate once daily with a 10-day course of oral linezolid twice daily for treatment of acute bacterial skin and skin structure infections (ABSSSIs). Among 667 adults with ABSSSIs randomized to treatment with tedizolid phosphate (n = 332) or linezolid (n = 335), the early clinical treatment response rates were 79.5% with tedizolid phosphate and 79.4% with linezolid, a treatment difference of 0.1% (95% CI, −6.1% to 6.2%). The sustained clinical treatment response rates at the end of treatment (day 11) were 69.3% with tedizolid phosphate and 71.9% with linezolid (a treatment difference of −2.6% [95% CI, −9.6% to 4.2%]), with the lower bounds of the 95% confidence intervals within the prespecified 10% noninferiority margin. The authors concluded that tedizolid phosphate was statistically noninferior to linezolid in achieving early clinical response after initiating therapy for ABSSSI.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2013.604
UR  - http://dx.doi.org/10.1001/jama.2013.604
ER  -