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

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

Author information

1
Department of Medicine, Duke University Medical Center, Durham, North Carolina.
2
Department of Medicine, University of California San Francisco.
3
Department of Medicine, Tufts Medical Center, Boston, Massachusetts.
4
Theravance Biopharma US, Inc., South San Francisco, California.

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

PMID:
30202941
PMCID:
PMC6376080
[Available on 2019-09-10]
DOI:
10.1093/cid/ciy774

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