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 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 tha... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2020 |
Reihe/Periodikum: | Trials ; volume 21, issue 1 ; ISSN 1745-6215 |
Verlag/Hrsg.: |
Springer Science and Business Media LLC
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Schlagwörter: | Pharmacology (medical) / Medicine (miscellaneous) |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-26895060 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | http://dx.doi.org/10.1186/s13063-020-4102-0 |
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 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 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. Conclusion 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. Trial registration ClinicalTrials.gov , NCT01792804 . Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77