| Title: |
Analysis of the Phase 3 ESTABLISH Trials of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections |
| Authors: |
Shorr, Andrew F.; Lodise, Thomas P.; Corey, G. Ralph; De Anda, Carisa; Fang, Edward; Das, Anita F.; Prokocimer, Philippe |
| Source: |
Antimicrobial Agents and Chemotherapy ; volume 59, issue 2, page 864-871 ; ISSN 0066-4804 1098-6596 |
| Publisher Information: |
American Society for Microbiology |
| Publication Year: |
2015 |
| Description: |
Tedizolid, a novel oxazolidinone with activity against a wide range of Gram-positive pathogens, was evaluated in two noninferiority phase 3 acute bacterial skin and skin structure infection trials. The data from individual trials showed its noninferior efficacy compared to that of linezolid and a favorable tolerability profile. To evaluate potential differences, the pooled data were analyzed. The patients received 200 mg of tedizolid once daily for 6 days or 600 mg of linezolid twice daily for 10 days. Efficacy was evaluated at 48 to 72 h (primary endpoint), on days 11 to 13 (end of therapy [EOT]), and 7 to 14 days after the EOT (posttherapy evaluation). Treatment-emergent adverse events and hematologic and clinical laboratory parameters were collected. The baseline characteristics were comparable between the treatment groups: 852/1,333 (64%) patients were from North America, and the majority of infections were caused by Staphylococcus aureus . Tedizolid was noninferior to linezolid (early clinical responses, 81.6% versus 79.4%, respectively). The early responses remained relatively consistent across various host/disease factors and severity measures. Nausea was the most frequently reported adverse event (tedizolid, 8.2%; linezolid, 12.2%; P = 0.02), with onset occurring primarily during the first 6 days. Fewer tedizolid than linezolid patients had platelet counts of |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1128/aac.03688-14 |
| DOI: |
10.1128/AAC.03688-14 |
| Availability: |
https://doi.org/10.1128/aac.03688-14; https://journals.asm.org/doi/pdf/10.1128/AAC.03688-14 |
| Rights: |
https://journals.asm.org/non-commercial-tdm-license |
| Accession Number: |
edsbas.C5BA4896 |
| Database: |
BASE |