{"id":25963,"date":"2024-08-29T04:24:00","date_gmt":"2024-08-28T20:24:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=25963"},"modified":"2024-08-29T10:18:41","modified_gmt":"2024-08-29T02:18:41","slug":"lancet-infect-dis%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e4%bd%8e%e9%a3%8e%e9%99%a9%e9%87%91%e9%bb%84%e8%89%b2%e8%91%a1%e8%90%84%e7%90%83%e8%8f%8c%e8%a1%80%e6%b5%81%e6%84%9f%e6%9f%93%e6%82%a3","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=25963","title":{"rendered":"[Lancet Infect Dis\u53d1\u8868\u8bba\u6587]\uff1a\u4f4e\u98ce\u9669\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc\u8840\u6d41\u611f\u67d3\u60a3\u8005\u65e9\u671f\u53e3\u670d\u5e8f\u8d2f\u6297\u751f\u7d20\u6cbb\u7597\u7684\u7597\u6548\u4e0e\u5b89\u5168\u6027"},"content":{"rendered":"\n<p>ARTICLES|<a href=\"https:\/\/www.thelancet.com\/journals\/laninf\/issue\/vol24no5\/PIIS1473-3099(24)X0005-5\">\u00a0VOLUME 24, ISSUE 5<\/a>,\u00a0P523-534,\u00a0MAY 2024<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Efficacy and safety of an early oral switch in low-risk\u00a0<em>Staphylococcus aureus<\/em>\u00a0bloodstream infection (SABATO): an international, open-label, parallel-group, randomised, controlled, non-inferiority trial<\/h1>\n\n\n\n<h3 class=\"wp-block-heading\">Achim J Kaasch, Luis Eduardo L\u00f3pez-Cort\u00e9s, Jes\u00fas Rodr\u00edguez-Ba\u00f1o, et al<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">Lancet Infect Dis 2024; 24: 523-534 Published:January 17, 2024<\/h3>\n\n\n\n<h3 class=\"wp-block-heading\">DOI: <a href=\"https:\/\/doi.org\/10.1016\/S1473-3099(23)00756-9\">https:\/\/doi.org\/10.1016\/S1473-3099(23)00756-9<\/a><\/h3>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"seccestitle10\">Summary<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Background<\/h3>\n\n\n\n<p><em>Staphylococcus aureus<\/em>&nbsp;bloodstream infection is treated with at least 14 days of intravenous antimicrobials. We assessed the efficacy and safety of an early switch to oral therapy in patients at low risk for complications related to&nbsp;<em>S aureus<\/em>&nbsp;bloodstream infection.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Methods<\/h3>\n\n\n\n<p>In this international, open-label, randomised, controlled, non-inferiority trial done in 31 tertiary care hospitals in Germany, France, the Netherlands, and Spain, adult patients with low-risk&nbsp;<em>S aureus<\/em>&nbsp;bloodstream infection were randomly assigned after 5\u20137 days of intravenous antimicrobial therapy to oral antimicrobial therapy or to continue intravenous standard therapy. Randomisation was done via a central web-based system, using permuted blocks of varying length, and stratified by study centre. The main exclusion criteria were signs and symptoms of complicated&nbsp;<em>S aureus<\/em>&nbsp;bloodstream infection, non-removable foreign devices, and severe comorbidity. The composite primary endpoint was the occurrence of any complication related to&nbsp;<em>S aureus<\/em>&nbsp;bloodstream infection (relapsing&nbsp;<em>S aureus<\/em>&nbsp;bloodstream infection, deep-seated infection, and mortality attributable to infection) within 90 days, assessed in the intention-to-treat population by clinical assessors who were masked to treatment assignment. Adverse events were assessed in all participants who received at least one dose of study medication (safety population). Due to slow recruitment, the scientific advisory committee decided on Jan 15, 2018, to stop the trial after 215 participants were randomly assigned (planned sample size was 430 participants) and to convert the planned interim analysis into the final analysis. The decision was taken without knowledge of outcome data, at a time when 126 participants were enrolled. The new sample size accommodated a non-inferiority margin of 10%; to claim non-inferiority, the upper bound of the 95% CI for the treatment difference (stratified by centre) had to be below 10 percentage points. The trial is closed to recruitment and is registered with&nbsp;<a href=\"http:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a>&nbsp;(<a href=\"http:\/\/clinicaltrials.gov\/show\/NCT01792804\" target=\"_blank\" rel=\"noreferrer noopener\">NCT01792804<\/a>), the German Clinical trials register (DRKS00004741), and EudraCT (2013\u2013000577\u201377).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Findings<\/h3>\n\n\n\n<p>Of 5063 patients with\u00a0<em>S aureus<\/em>\u00a0bloodstream infection assessed for eligibility, 213 were randomly assigned to switch to oral therapy (n=108) or to continue intravenous therapy (n=105). Mean age was 63\u00b75 (SD 17\u00b72) years and 148 (69%) participants were male and 65 (31%) were female. In the oral switch group, 14 (13%) participants met the primary endpoint versus 13 (12%) in the intravenous group, with a treatment difference of 0\u00b77 percentage points (95% CI \u20137\u00b78 to 9\u00b71; p=0\u00b7013). In the oral switch group, 36 (34%) of 107 participants in the safety population had at least one serious adverse event compared with 27 (26%) of 103 participants in the intravenous group (p=0\u00b729).<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/ars.els-cdn.com\/content\/image\/1-s2.0-S1473309923007569-gr1_lrg.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" src=\"https:\/\/ars.els-cdn.com\/content\/image\/1-s2.0-S1473309923007569-gr2_lrg.jpg\" alt=\"\"\/><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">Interpretation<\/h3>\n\n\n\n<p>Oral switch antimicrobial therapy was non-inferior to intravenous standard therapy in participants with low-risk&nbsp;<em>S aureus<\/em>bloodstream infection. However, it is necessary to carefully assess patients for signs and symptoms of complicated&nbsp;<em>S aureus<\/em>bloodstream infection at the time of presentation and thereafter before considering early oral switch therapy.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Funding<\/h3>\n\n\n\n<p>Deutsche Forschungsgemeinschaft.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ARTICLES|\u00a0VOLUME 24, ISSUE 5,\u00a0P523-534,\u00a0MAY 2024 Effica [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25963"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=25963"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25963\/revisions"}],"predecessor-version":[{"id":25964,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25963\/revisions\/25964"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25963"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25963"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25963"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}