Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial

Tedizolid in skin and skin structure infections: brave new world?

“…Taken together, these two trials [8,9] have demonstrated the noninferiority of tedizolid (early clinical responses 81.6% vs. 79.4%, respectively) along with its improved tolerability and safety profile compared with linezolid, particularly in terms of gastrointestinal adverse events and hematological parameters. The most frequently reported adverse event was nausea (tedizolid 8.2%; linezolid 12.2%; p = 0.02), whereas fewer tedizolid-treated than linezolid-treated patients exhibited low platelet counts [10].…”

“…A further trial, Efficacy and Safety of 6-day Oral Tedizolid in Acute Bacterial Skin and Skin Structure Infections vs. 10-day Oral Linezolid Therapy-2 (ESTABLISH-2), randomized patients to either intravenous tedizolid phosphate 200 mg once daily for 6 days or intravenous linezolid 600 mg twice daily for 10 days, with optional oral step-down [9]. Once again, noninferiority was documented for tedizolid [9].…”

“…Other advantages include the availability of both oral and intravenous routes of administration, the short course of therapy, the convenient dosing scheme, and the trend toward less hematological toxicity [8][9][10][11][12]. Taken these advantages into consideration, tedizolid appears increasingly preferable to linezolid in ABSSSIs.…”

New Antibiotics in the Therapy of Osteomyelitis

“…Its spectrum covers Grampositive pathogens, including linezolid-resistant S. aureus [101] . It has been shown to be efficient, safe and well-tolerated in phase 3 studies and a post-hoc analysis for Latino patients [101][102][103] . Its efficiency has been studied in rat foreign-body osteomyelitis, but no data for human osteomyelitis exists [104] .…”

Dalbavancin, Oritavancin and Tedizolid are Safe and Effective for Skin Infection Treatment

“…Intravenous to oral once-daily tedizolid 200 mg for 6 days is non-inferior to twice-daily linezolid 600 mg for 10 days for treatment of patients with acute bacterial skin and skin-structure infections. Tedizolid could become a useful option for the treatment of acute bacterial skin and skin-structure infections in the hospital and outpatient settings (6). Studies have shown that the efficacy of dalbavancin administered once weekly, Oritavancin single dose and tedizolid 200 mg daily for 6 days are not inferior to that of a conventional twice daily antibiotic regimen with vancomycin or other glycopeptides and the early primary end point of cessation of the spread of infection and the absence of fever showed a consistent treatment effect regarding a reduction in the area of infection (4)(5)(6).…”