Tedizolid rivals linezolid for complicated skin infections.
Tedizolid was found to be noninferior to linezolid for the treatment of acute, complicated infections of the skin and skin structure, including methicillin-resistant Staphylococcus aureus infections, according to a report.
In a phase III, randomized clinical trial, oral tedizolid phosphate (also known as TR-701) was at least as effective as oral linezolid early in the course of infection (at 48-72 hours after initiating therapy), and response to the drug persisted at a later follow-up at 7-14 days after treatment ended. Early effectiveness is important because clinicians decide whether to continue with their chosen agent or switch to different drugs during that period. Tedizolid offers an advantage over linezolid in that it requires only once-daily dosing of a 200-mg tablet for a total of 6 days; the standard course of linezolid requires twice-daily dosing of a 600-mg tablet for 10 days. In this trial, tedizolid produced fewer gastrointestinal adverse effects and halved the rate of low platelet counts, compared with linezolid, said Dr. Philippe Prokocimer of Trius Therapeutics, San Diego, and his associates.
Trius, the maker of tedizolid, funded and conducted this 1-year, double-blind study at 54 medical centers in North America, Latin America, and Europe.
The researchers compared the two antibiotics in 667 adults (age range, 18-100 years) who had cellulitis/ erysipelas, major cutaneous abscess, or wound infection surrounded by erythema, with a minimum total lesion surface of 75 [cm.sup.2]. The study subjects also had at least one local and one regional or one systemic sign of infection, and the infecting organism was either thought to be or proven to be a gram-positive pathogen. The subjects were stratified by the presence or absence of fever at baseline, the geographic region where they resided, and the type of infection they had, and then randomly assigned to receive tedizolid (332 patients) or linezolid (335 patients). Both groups presented a similar clinical picture, with a median infected area of 188 cm; 87% of the study population had lymphadenopathy adjacent to the lesion, 41% had abnormal white blood cell counts, and 18% were febrile.
In the primary efficacy intention-to-treat analysis, 79.5% of the subjects receiving tedizolid and 79.4% receiving linezolid were classified as responders -- meaning they were afebrile and their primary skin lesions had stopped spreading -- when evaluated at 48-72 hours after the first dose of the antibiotics. Conversely, 8.1% of the subjects receiving tedizolid and 10.4% of those receiving linezolid were true nonresponders, with fever or continued spread of the primary lesion, at 48-72 hours. Thus, tedizolid met the criteria for noninferiority to linezolid at this time point, Dr. Prokocimer and his colleagues reported (JAMA 2013;309:559-69). The investigators reported ties to numerous drug companies.
BY MARY ANN MOON
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|Author:||Moon, Mary Ann|
|Publication:||Family Practice News|
|Date:||Mar 1, 2013|
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