Universität zu Köln

Kaasch, Achim J., Rommerskirchen, Anna, Hellmich, Martin, Faetkenheuer, Gerd, Prinz-Langenohl, Reinhild, Rieg, Siegbert ORCID: 0000-0001-7493-7080, Kern, Winfried, V and Seifert, Harald (2020). Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection. Trials, 21 (1). LONDON: BMC. ISSN 1745-6215

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kaasch, Achim J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rommerskirchen, Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Faetkenheuer, Gerd UNSPECIFIED UNSPECIFIED UNSPECIFIED Prinz-Langenohl, Reinhild UNSPECIFIED UNSPECIFIED UNSPECIFIED Rieg, Siegbert UNSPECIFIED orcid.org/0000-0001-7493-7080 UNSPECIFIED Kern, Winfried, V UNSPECIFIED UNSPECIFIED UNSPECIFIED Seifert, Harald UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-344892
DOI:	10.1186/s13063-020-4102-0
Journal or Publication Title:	Trials
Volume:	21
Number:	1
Date:	2020
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34489