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Omadacycline for Acute Bacterial Skin and Skin‐Structure InfectionsThe New England Journal of Medicine, 380
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(2010)
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
- Publisher
- The New England Journal of Medicine
- Copyright
- Copyright © 2019 Massachusetts Medical Society. All rights reserved.
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- DOI
- 10.1056/NEJMe1900188
- Publisher site
- See Article on Publisher Site
Abstract
Omadacycline was the second antibiotic of the tetracycline class to be approved by the Food and Drug Administration (FDA) in 2018. Results of two phase 3, double-blind, randomized clinical trials of the drug, one involving acute bacterial skin and skin-structure infections and the other community-acquired bacterial pneumonia, are now reported in the Journal.1,2 Each trial was designed and executed according to FDA guidance.3,4 The primary efficacy end point in each was early clinical response, at 48 to 72 hours for acute bacterial skin and skin-structure infections and at 72 to 120 hours for community-acquired bacterial pneumonia, in an intention-to-treat population. . . .
Journal
The New England Journal of Medicine – The New England Journal of Medicine
Published: Feb 7, 2019