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


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.

SUBMITTER: Holland TL 

PROVIDER: S-EPMC6376080 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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

Holland Thomas L TL   Chambers Henry F HF   Boucher Helen W HW   Corey G Ralph GR   Coleman Rebecca R   Castaneda-Ruiz Bibiana B   Fowler Vance G VG  

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20190201 5


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  ...[more]

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