Tedizolid phosphate was noninferior to linezolid for the treatment of acute bacterial skin and skin structure infections, researchers reported in the Journal of the American Medical Association.
“The take-home message from the efficacy perspective is that, if approved, tedizolid will be the first antibiotic labeled for a fixed 6-day course of once-daily treatment for severe bacterial skin infections,” Philippe Prokocimer, MD, chief medical officer of Trius Therapeutics, told Infectious Disease News. “From a safety perspective, the study showed a lower number of gastrointestinal adverse events and a lower impact on platelets.”
The ESTABLISH-1 trial was a randomized, phase 3, double blind, noninferiority trial in which patients received a 200 mg once-daily dose of oral tedizolid phosphate for 6 days or 600 mg of oral linezolid every 12 hours for 10 days. From August 2010 to September 2011, 667 adults with acute bacterial skin and skin structure infections from 81 centers were enrolled.
In the intent-to-treat analysis, the early clinical treatment response rate was 79.5% among patients treated with tedizolid and 79.4% for the patients treated with linezolid. The sustained clinical response rate at day 11 was 69.3% for tedizolid and 71.9% for linezolid. Success rates 1 to 2 weeks after end-of-treatment visits were 85.5% for tedizolid and 86% for linezolid. These rates were similar for patients with methicillin-resistant Staphylococcus aureus.
“All other results of the tedizolid program have been very consistent from the preclinical phase through the testing in phase 3 trials,” Prokocimer said. “The once-daily, 6-day course of therapy may enable earlier discharge from the hospital and result in high compliance, which may result in both low treatment cost and resistance development.”
Prokocimer said data from a phase 1 study have also shown that tedizolid may be a potential treatment for pneumonia as well.
Disclosure: Prokocimer is an employee of Trius Therapeutics.