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- Title
Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection.
- Authors
Kaasch, Achim J.; Rommerskirchen, Anna; Hellmich, Martin; Fätkenheuer, Gerd; Prinz-Langenohl, Reinhild; Rieg, Siegbert; Kern, Winfried V.; Seifert, Harald; SABATO trial group
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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 cardioverter-defibrillator) became eligible for enrollment under certain conditions; (2) the target sample size was decreased by choosing a conventional non-inferiority margin of 10% and converting the interim analysis (215 patients) into the final analysis; and (3) an additional follow-up visit after 30 days was introduced to allow for a closer follow-up of patients.<bold>Conclusion: </bold>Changes to the study protocol were introduced to improve the enrollment and follow-up of patients. Furthermore, the decrease of the sample size will facilitate completion of the trial.<bold>Trial Registration: </bold>ClinicalTrials.gov, NCT01792804. Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77.
- Subjects
STAPHYLOCOCCUS aureus infections; DEFIBRILLATORS; RANDOMIZED controlled trials; IMPLANTABLE cardioverter-defibrillators; CHRONIC kidney failure; EXPERIMENTAL design; FOREIGN bodies; JOHN Cunningham virus
- Publication
Trials, 2020, Vol 21, Issue 1, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-020-4102-0