Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults

Clin Infect Dis. 2019 Feb 15;68(5):865-872. doi: 10.1093/cid/ciy774.

Abstract

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.

Keywords: Staphylococcus aureus; bacteremia; clinical trials.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Anti-Bacterial Agents / therapeutic use*
  • Clinical Trials as Topic / methods*
  • Humans
  • Research Design / legislation & jurisprudence*
  • Sepsis / drug therapy
  • Sepsis / microbiology*
  • Staphylococcal Infections / drug therapy*
  • Staphylococcal Infections / microbiology
  • Staphylococcus aureus*

Substances

  • Anti-Bacterial Agents