scholarly journals Integrated Analysis of CANVAS 1 and 2: Phase 3, Multicenter, Randomized, Double‐Blind Studies to Evaluate the Safety and Efficacy of Ceftaroline versus Vancomycin plus Aztreonam in Complicated Skin and Skin‐Structure Infection

2010 ◽  
Vol 51 (6) ◽  
pp. 641-650 ◽  
Author(s):  
G. Ralph Corey ◽  
Mark Wilcox ◽  
George H. Talbot ◽  
H. David Friedland ◽  
Tanya Baculik ◽  
...  
Keyword(s):  
Skin Structure Infection ◽  
Integrated Analysis ◽  
Phase 3 ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Skin Structure ◽  
Structure Infection ◽  
Complicated Skin

scholarly journals Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection

2019 ◽  
Vol 63 (7) ◽  
Author(s):  
Xiaoju Lv ◽  
Jeff Alder ◽  
Li Li ◽  
William O’Riordan ◽  
Michael J. Rybak ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
The Philippines ◽  
Skin Structure Infection ◽  
Clinical Response Rate ◽  
Phase 3 ◽  
Skin Structure ◽  
Treatment Difference ◽  
Structure Infection ◽  
Secondary Endpoints

ABSTRACT Tedizolid phosphate is approved for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria in the United States, Europe, and other countries. In this multicenter, double-blind, phase 3 study, 598 adult ABSSSI patients in China, Taiwan, the Philippines, and the United States were randomized to receive 200 mg of tedizolid, intravenously (i.v.)/orally (p.o.), once daily for 6 days or 600 mg of linezolid, i.v./p.o. twice daily for 10 days. The primary endpoint was early clinical response rate at 48 to 72 h. Secondary endpoints included programmatic and investigator-assessed outcomes at end-of-therapy (EOT) and posttherapy evaluation (PTE) visits. Safety was also evaluated. In the intent-to-treat (ITT) population, 75.3% of tedizolid-treated patients and 79.9% of linezolid-treated patients were early responders (treatment difference, –4.6%; 95% confidence interval [CI], –11.2, 2.2). After exclusion of patients who never received the study drug (tedizolid, n = 8; linezolid, n = 1; modified ITT), comparable early response rates were observed (tedizolid, 77.4%; linezolid, 80.1%; treatment difference, –2.7%; 95% CI, –9.4, 3.9). Secondary endpoints showed high and similar clinical success rates in the ITT and clinically evaluable (CE) populations at EOT and PTE visits (e.g., CE-PTE for tedizolid, 90.4%; for linezolid, 93.5%). Both drugs were well tolerated, and no death occurred. Eight patients experienced phlebitis with tedizolid while none did with linezolid; hence, drug-related treatment-emergent adverse events were reported in a slightly higher proportion in the tedizolid (20.9%) arm than in the linezolid arm (15.8%). The study demonstrated that tedizolid in a primarily Asian population was an efficacious and well-tolerated treatment option for ABSSSI patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT02066402.)

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