Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults | Zendy

Thomas L Holland | Zendy; Henry F. Chambers | Zendy; Helen W. Boucher | Zendy; G. Ralph Corey | Zendy; Rebecca Coleman | Zendy; Bibiana Castañeda-Ruiz | Zendy; Vance G. Fowler | Zendy

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Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults

Author(s) -

Thomas L Holland,

Henry F. Chambers,

Helen W. Boucher,

G. Ralph Corey,

Rebecca Coleman,

Bibiana Castañeda-Ruiz,

Vance G. Fowler

Publication year - 2018

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/ciy774

Subject(s) - medicine , clinical trial , staphylococcus aureus , antibiotics , intensive care medicine , bloodstream infection , staphylococcal infections , microbiology and biotechnology , bacteria , biology , genetics

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.

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