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Tedizolid and linezolid for treatment of acute bacterial skin and skin structure infections of the lower extremity versus non–lower-extremity infections : pooled analysis of two phase 3 trials / Warren S. Joseph in Journal of the American Podiatric Medical Association, vol. 107, 4 (Juillet- août 2017)
[article]
in Journal of the American Podiatric Medical Association > vol. 107, 4 (Juillet- août 2017) . - p. 264-271
Titre : Tedizolid and linezolid for treatment of acute bacterial skin and skin structure infections of the lower extremity versus non–lower-extremity infections : pooled analysis of two phase 3 trials Type de document : article de périodique Auteurs : Warren S. Joseph, Auteur ; [et al.], Auteur Année de publication : 2017 Article en page(s) : p. 264-271 Langues : Anglais (eng) Descripteurs (mots clés) : [Thésaurus Mesh]:D:Dermatoses bactériennes:Dermatoses bactériennes / traitement médicamenteux
[Thésaurus Mesh]Infections bactériennes
[Thésaurus Mesh]Membre inférieur
[Thésaurus Mesh]Membre supérieur
[Thésaurus Mesh]Pied diabétique
[Thésaurus HELB]:Paramédical:Comparaison
[Thésaurus HELB]:Paramédical:Linézolide
[Thésaurus HELB]:Paramédical:Phosphate de tédizolideMots-clés : torezolid phosphate Linezolid bacterial infections drug therapy lower extremity diabetic foot upper extremity Résumé : Background: Tedizolid phosphate, the prodrug of the oxazolidinone tedizolid, has been approved in a number of countries, including the United States, those in the European Union, and Canada, for treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Two phase 3 trials demonstrated the noninferior efficacy of tedizolid (200 mg once daily for 6 days) to linezolid (600 mg twice daily for 10 days) in patients with ABSSSI. Because of the challenges of treating lower-extremity ABSSSI, the efficacy and safety of tedizolid and linezolid for treating lower-extremity versus non– lower-extremity infections were compared.
Methods: This was a post hoc analysis of pooled data from patients with lower-extremity infections enrolled in two phase 3 studies, ESTABLISH-1 (NCT01170221) and ESTABLISH-2 (NCT01421511), comparing tedizolid to linezolid in patients with ABSSSI.
Results: Lower-extremity ABSSSI were present in 40.7% of tedizolid-treated and 42.2% of linezolid-treated patients. Methicillin-resistant Staphylococcus aureus (MRSA) was present in 34.7% of all patients with a baseline causative pathogen. Early clinical responses at 48 to 72 hours and investigator-assessed responses at the post-therapy evaluation were similar between tedizolid and linezolid, regardless of ABSSSI type. With both treatments, the early clinical response was slightly higher in patients with non– lower-extremity infection than in those with lower-extremity ABSSSI (tedizolid, 84.8% versus 77.0%; linezolid, 81.4% versus 76.6%, respectively); however, by the posttherapy evaluation visit, response rates were similar (tedizolid, 87.1% versus 86.3%; linezolid, 86.6% versus 87.2%, respectively). Gastrointestinal adverse events and low platelet counts were observed more frequently with linezolid treatment.
Conclusions: Post-therapy evaluations showed that the clinical response of lowerextremity ABSSSI to tedizolid and linezolid was comparable to that of ABSSSI in other locations. A short 6-day course of once-daily tedizolid was as effective as a 10-day course of twice-daily linezolid in treating patients with lower-extremity ABSSSI
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