{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T14:00:09Z","timestamp":1778853609370,"version":"3.51.4"},"reference-count":6,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","award":["KA 3104\/2"],"award-info":[{"award-number":["KA 3104\/2"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>SABATO (<jats:italic>Staphylococcus aureus<\/jats:italic> 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 <jats:italic>Staphylococcus aureus<\/jats:italic> infection. The original trial protocol was published in <jats:italic>Trials<\/jats:italic> (accessible at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"doi\" xlink:href=\"https:\/\/doi.org\/10.1186\/s13063-015-0973-x  \">10.1186\/s13063-015-0973-x<\/jats:ext-link>). Here we describe final amendments to the study protocol and discuss the underlying rationale.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods\/design<\/jats:title>\n<jats:p>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\u2009days was introduced to allow for a closer follow-up of patients.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>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.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01792804\">NCT01792804<\/jats:ext-link>. Registered on 13 February 2013.<\/jats:p>\n<jats:p>German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-4102-0","type":"journal-article","created":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T13:03:00Z","timestamp":1581512580000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection"],"prefix":"10.1186","volume":"21","author":[{"name":"for the SABATO trial group","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6659-6738","authenticated-orcid":false,"given":"Achim J.","family":"Kaasch","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Rommerskirchen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Hellmich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerd","family":"F\u00e4tkenheuer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reinhild","family":"Prinz-Langenohl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siegbert","family":"Rieg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Winfried V.","family":"Kern","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harald","family":"Seifert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,2,12]]},"reference":[{"key":"4102_CR1","doi-asserted-by":"crossref","unstructured":"Nambiar K, Seifert H, Rieg S, Kern WV, Scarborough M, Gordon NC, et al. Survival following Staphylococcus aureus bloodstream infection. A prospective multinational cohort study assessing the impact of place of care. J Infect. 2018;77(6):516\u201325.","DOI":"10.1016\/j.jinf.2018.08.015"},{"key":"4102_CR2","doi-asserted-by":"publisher","first-page":"450","DOI":"10.1186\/s13063-015-0973-x","volume":"16","author":"AJ Kaasch","year":"2015","unstructured":"Kaasch AJ, F\u00e4tkenheuer G, Prinz-Langenohl R, Paulus U, Hellmich M, Wei\u00df V, et al. Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO). Study protocol for a randomized controlled trial. Trials. 2015;16:450.","journal-title":"Trials"},{"issue":"4","key":"4102_CR3","doi-asserted-by":"publisher","first-page":"332","DOI":"10.1016\/j.jinf.2019.08.001","volume":"79","author":"Alexander Szubert","year":"2019","unstructured":"Szubert A, Bailey SL, Cooke GS, Peto T, Llewelyn MJ, Edgeworth JD, et al. Predictors of recurrence, early treatment failure and death from Staphylococcus aureus bacteraemia. Observational analyses within the ARREST trial. J Infect. 2019;79(4):332\u201340.","journal-title":"Journal of Infection"},{"issue":"3","key":"4102_CR4","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1016\/j.jinf.2013.04.018","volume":"67","author":"L. Wiese","year":"2013","unstructured":"Wiese L, Mejer N, Sch\u00f8nheyder HC, Westh H, Jensen AG, Larsen AR, et al. A nationwide study of comorbidity and risk of reinfection after Staphylococcus aureus bacteraemia. J Infect. 2013;67(3):199\u2013205.","journal-title":"Journal of Infection"},{"issue":"11","key":"4102_CR5","doi-asserted-by":"publisher","first-page":"1814","DOI":"10.2215\/CJN.02320317","volume":"12","author":"MS Chaudry","year":"2017","unstructured":"Chaudry MS, Carlson N, Gislason GH, Kamper AL, Rix M, Fowler VG Jr, et al. Risk of Infective endocarditis in patients with end stage renal disease. Clin J Am Soc Nephrol. 2017;12(11):1814\u201322.","journal-title":"Clin J Am Soc Nephrol"},{"key":"4102_CR6","doi-asserted-by":"publisher","unstructured":"Kaasch AJ, Kern WV, Joost I, Hellmich M, Seifert H, Rieg S. Effect of clinically uninfected orthopedic implants and pacemakers\/AICDs in low-risk Staphylococcus aureus bloodstream infection on crude mortality rate. A post hoc analysis of a large cohort study. Open Forum Infect Dis. 2019. https:\/\/doi.org\/10.1093\/ofid\/ofz170  .","DOI":"10.1093\/ofid\/ofz170"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-4102-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-020-4102-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-4102-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,11]],"date-time":"2021-02-11T09:52:51Z","timestamp":1613037171000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-4102-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,12]]},"references-count":6,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4102"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-4102-0","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,2,12]]},"assertion":[{"value":"31 October 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 January 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 February 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study amendments were approved by the coordinating Ethics Committees for participating countries and by the individual Ethics Committees of the participating study sites.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"175"}}