Bibliographic Details
| 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: |
Achim J. Kaasch, Anna Rommerskirchen, Martin Hellmich, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Siegbert Rieg, Winfried V. Kern, Harald Seifert, for the SABATO trial group |
| Source: |
Trials, Vol 21, Iss 1, Pp 1-3 (2020) |
| Publisher Information: |
BMC, 2020. |
| Publication Year: |
2020 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
Oral switch therapy, Intravenous, Antimicrobial, Bloodstream infection, Bacteremia, Staphylococcus aureus, Medicine (General), R5-920 |
| More Details: |
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 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 |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1745-6215 |
| Relation: |
https://doaj.org/toc/1745-6215 |
| DOI: |
10.1186/s13063-020-4102-0 |
| Access URL: |
https://doaj.org/article/56cb1cf9fd4e4da494c6441b950a927d |
| Accession Number: |
edsdoj.56cb1cf9fd4e4da494c6441b950a927d |
| Database: |
Directory of Open Access Journals |
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