Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials.

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dc.contributor.authorLodise, Thomas P
dc.contributor.authorFang, Edward
dc.contributor.authorMinassian, Sonia L
dc.contributor.authorProkocimer, Philippe
dc.contributor.orcidhttps://orcid.org/0000-0002-4730-0655
dc.date.accessioned2025-02-07T19:35:02Z
dc.date.available2025-02-07T19:35:02Z
dc.date.issued2014-12
dc.description.abstractTedizolid, the active moiety of tedizolid phosphate, is a recently approved oxazolidinone antibacterial with activity against a wide range of Gram-positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus. To date, 6 days of 200 mg tedizolid once daily has been shown to be noninferior to 10 days of 600 mg linezolid twice daily in two randomized, double-blind phase 3 trials (ESTABLISH-1 and ESTABLISH-2) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). The intent of this study was to characterize the platelet profiles of patients receiving tedizolid relative to linezolid over the course of treatment using pooled data from these two trials. The occurrences of clinically defined and statistical analysis plan-specified reduced platelet counts were assessed at the study days 7 to 9 visit, the study days 11 to 13 visit, and the posttherapy evaluation (PTE) visit. At the study days 7 to 9 visit, incidences of reduced platelet counts were low and largely similar between the groups. The only notable difference was a lower incidence of thrombocytopenia (platelet counts, <150,000 cells/mm(3)) among patients who received tedizolid (3.2%) relative to those who received linezolid (5.6%). At the study days 11 to 13 visit, patients who received tedizolid had lower incidences of platelet counts of <150,000 cells/mm(3) (-5.9%), <112,500 cells/mm(3) (-2.4%), and <100,000 cells/mm(3) (-1.9%) than patients in the linezolid group. Similar differences were noted at the PTE visit. Findings across the two phase 3 ABSSSI trials suggest that 6 days of 200 mg tedizolid daily confers a low potential for reduced platelet counts among patients with ABSSSIs. (The ESTABLISH-1 and ESTABLISH-2 trials have been registered at ClinicalTrials.gov under registration numbers NCT01170221 and NCT01421511, respectively.).
dc.description.urihttps://doi.org/10.1128/AAC.03509-14
dc.description.urihttp://www.ncbi.nlm.nih.gov/pmc/articles/pmc4249542
dc.identifier.citationLodise TP, Fang E, Minassian SL, Prokocimer PG. Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials. Antimicrob Agents Chemother. 2014 Dec;58(12):7198-204. doi: 10.1128/AAC.03509-14. Epub 2014 Sep 22. PMID: 25246392; PMCID: PMC4249542.
dc.identifier.issn0066-4804
dc.identifier.other25246392
dc.identifier.urihttps://hdl.handle.net/20.500.14303/787
dc.language.isoen
dc.publisherAmerican Society for Microbiology
dc.relation.ispartofAntimicrobial Agents and Chemotherapy
dc.rightsThis Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s). http://rightsstatements.org/vocab/InC/1.0/
dc.subjectAcetamides/therapeutic use
dc.subjectAnti-Bacterial Agents/therapeutic use
dc.subjectBlood Platelets/pathology
dc.subjectDouble-Blind Method
dc.subjectDrug Administration Schedule
dc.subjectLinezolid
dc.subjectMethicillin-Resistant Staphylococcus aureus/drug effects/growth & development
dc.subjectOxazolidinones/therapeutic use
dc.subjectPlatelet Count
dc.subjectStaphylococcal Skin Infections/drug therapy/microbiology/pathology
dc.subjectTetrazoles/therapeutic use
dc.titlePlatelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials.
dc.typeArticle
local.departmentprogramDepartment of Pharmacy Practice
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