Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults.

Published

Journal Article

Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are broadly grouped into 2 categories: registrational trials intended to support regulatory approval of antibiotics for the treatment of SAB and strategy trials intended to inform clinicians on the best treatment options for SAB among existing antibiotics. Both types of SAB trials are urgently needed but have been limited by cost, complexity, and regulatory uncertainty. Here, we review key SAB trial design considerations for investigators, sponsors, and regulators.

Full Text

Duke Authors

Cited Authors

  • Holland, TL; Chambers, HF; Boucher, HW; Corey, GR; Coleman, R; Castaneda-Ruiz, B; Fowler, VG

Published Date

  • February 15, 2019

Published In

Volume / Issue

  • 68 / 5

Start / End Page

  • 865 - 872

PubMed ID

  • 30202941

Pubmed Central ID

  • 30202941

Electronic International Standard Serial Number (EISSN)

  • 1537-6591

Digital Object Identifier (DOI)

  • 10.1093/cid/ciy774

Language

  • eng

Conference Location

  • United States