title: Tedizolid phosphate for the management of acute bacterial skin and skin structure infections: efficacy summary.
abstract: The novel oxazolidinone tedizolid phosphate is in late-stage development for acute bacterial skin and skin structure infections (ABSSSIs). Preclinical and phase 1 trials have shown that 200-mg once-daily tedizolid phosphate dosing achieves the appropriate pharmacokinetic goals for optimal antimicrobial effect, and a randomized phase 2 dose-ranging trial confirmed that tedizolid phosphate may be an option for the treatment of ABSSSIs at the 200-mg dose, the lowest effective dose, over a mean of 6.4 days of therapy. In the first of two phase 3 trials, 6 days of 200-mg once-daily oral tedizolid phosphate (plus 4 days of placebo) was noninferior to 10 days of 600-mg twice-daily oral linezolid when evaluated at both the early (48- to 72-hour assessment) and test-of-cure (7-14 days after the last dose of active or placebo agent was given) time points. Initial results from the second phase 3 trial (intravenous to oral therapy design) confirm the study met all primary and secondary endpoints and continues to add insight into the clinical utility of tedizolid phosphate.
authors.affiliation: eStudySite.
authors.forename: William
authors.initials: W
authors.lastname: O'Riordan
authors.forename: Sinikka
authors.initials: S
authors.lastname: Green
authors.forename: Purvi
authors.initials: P
authors.lastname: Mehra
authors.forename: Carisa
authors.initials: C
authors.lastname: De Anda
authors.forename: Edward
authors.initials: E
authors.lastname: Fang
authors.forename: Philippe
authors.initials: P
authors.lastname: Prokocimer
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006801:Humans; D010755:Organophosphates / Q000627:therapeutic use*; D010080:Oxazoles / Q000627:therapeutic use*; D013207:Staphylococcal Skin Infections / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D010755:Organophosphates; D010080:Oxazoles; C515040:tedizolid phosphate
keywords: ABSSSI; MRSA; Staphylococcus aureus; efficacy; tedizolid phosphate