Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection.

ABSTRACT:

Background

SABATO (Staphylococcus aureus bacteremia antibiotic treatment options) is a randomized, parallel-group, clinical non-inferiority trial designed to examine the efficacy and safety of early oral switch therapy in low-risk Staphylococcus aureus infection. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-015-0973-x ). Here we describe final amendments to the study protocol and discuss the underlying rationale.

Methods/design

Three major changes were introduced into the study protocol: (1) the inclusion and exclusion criteria were refined so that patients with certain comorbidities (end-stage renal disease, severe liver disease) and uninfected foreign bodies (orthopedic prosthesis, pacemaker, implanted cardiac cardiovert

SUBMITTER: Kaasch AJ 

PROVIDER: S-EPMC7017556 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature