{"id":25860,"date":"2024-06-11T04:30:00","date_gmt":"2024-06-10T20:30:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=25860"},"modified":"2024-06-11T05:38:57","modified_gmt":"2024-06-10T21:38:57","slug":"lancet-infect-dis%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e8%82%a0%e6%9d%86%e8%8f%8c%e7%a7%91%e7%bb%86%e8%8f%8c%e8%a1%80%e6%b5%81%e6%84%9f%e6%9f%93%e6%97%b6%e4%bb%8e%e6%8a%97%e5%81%87%e5%8d%95","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=25860","title":{"rendered":"[Lancet Infect Dis\u53d1\u8868\u8bba\u6587]\uff1a\u80a0\u6746\u83cc\u79d1\u7ec6\u83cc\u8840\u6d41\u611f\u67d3\u65f6\u4ece\u6297\u5047\u5355\u80de\u03b2-\u5185\u9170\u80fa\u6297\u751f\u7d20\u8fdb\u884c\u7ed3\u6784\u6027\u964d\u9636\u68af\u6cbb\u7597\u7684\u6548\u679c\u4e0e\u5b89\u5168\u6027"},"content":{"rendered":"\n

ARTICLES|\u00a0VOLUME 24, ISSUE 4<\/a>,\u00a0P375-385,\u00a0APRIL 2024<\/p>\n\n\n\n

Efficacy and safety of a structured de-escalation from antipseudomonal \u03b2-lactams in bloodstream infections due to Enterobacterales (SIMPLIFY): an open-label, multicentre, randomised trial<\/h1>\n\n\n\n

Luis Eduardo L\u00f3pez-Cort\u00e9s, Mercedes Delgado-Valverde, Elisa Moreno-Mellado, et al<\/h3>\n\n\n\n

Lancet Infect Dis 2024; 24: 375-385<\/h3>\n\n\n\n

DOI:https:\/\/doi.org\/10.1016\/S1473-3099(23)00686-2<\/a><\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

De-escalation from broad-spectrum to narrow-spectrum antibiotics is considered an important measure to reduce the selective pressure of antibiotics, but a scarcity of adequate evidence is a barrier to its implementation. We aimed to determine whether de-escalation from an antipseudomonal \u03b2-lactam to a narrower-spectrum drug was non-inferior to continuing the antipseudomonal drug in patients with Enterobacterales bacteraemia.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

An open-label, pragmatic, randomised trial was performed in 21 Spanish hospitals. Patients with bacteraemia caused by Enterobacterales susceptible to one of the de-escalation options and treated empirically with an antipseudomonal \u03b2-lactam were eligible. Patients were randomly assigned (1:1; stratified by urinary source) to de-escalate to ampicillin, trimethoprim\u2013sulfamethoxazole (urinary tract infections only), cefuroxime, cefotaxime or ceftriaxone, amoxicillin\u2013clavulanic acid, ciprofloxacin, or ertapenem in that order according to susceptibility (de-escalation group), or to continue with the empiric antipseudomonal \u03b2-lactam (control group). Oral switching was allowed in both groups. The primary outcome was clinical cure 3\u20135 days after end of treatment in the modified intention-to-treat (mITT) population, formed of patients who received at least one dose of study drug. Safety was assessed in all participants. Non-inferiority was declared when the lower bound of the 95% CI of the absolute difference in cure rate was above the \u201310% non-inferiority margin. This trial is registered with EudraCT (2015-004219-19) and ClinicalTrials.gov<\/a> (NCT02795949<\/a>) and is complete.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

2030 patients were screened between Oct 5, 2016, and Jan 23, 2020, of whom 171 were randomly assigned to the de-escalation group and 173 to the control group. 164 (50%) patients in the de-escalation group and 167 (50%) in the control group were included in the mITT population. 148 (90%) patients in the de-escalation group and 148 (89%) in the control group had clinical cure (risk difference 1\u00b76 percentage points, 95% CI \u20135\u00b70 to 8\u00b72). The number of adverse events reported was 219 in the de-escalation group and 175 in the control group, of these, 53 (24%) in the de-escalation group and 56 (32%) in the control group were considered severe. Seven (5%) of 164 patients in the de-escalation group and nine (6%) of 167 patients in the control group died during the 60-day follow-up. There were no treatment-related deaths.<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

De-escalation from an antipseudomonal \u03b2-lactam in Enterobacterales bacteraemia following a predefined rule was non-inferior to continuing the empiric antipseudomonal drug. These results support de-escalation in this setting.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

Plan Nacional de I+D+i 2013\u20132016 and Instituto de Salud Carlos III, Subdirecci\u00f3n General de Redes y Centros de Investigaci\u00f3n Cooperativa, Ministerio de Ciencia, Innovaci\u00f3n y Universidades, Spanish Network for Research in Infectious Diseases; Spanish Clinical Research and Clinical Trials Platform, co-financed by the EU; European Development Regional Fund \u201cA way to achieve Europe\u201d, Operative Program Intelligence Growth 2014\u20132020.<\/p>\n","protected":false},"excerpt":{"rendered":"

ARTICLES|\u00a0VOLUME 24, ISSUE 4,\u00a0P375-385,\u00a0APRIL 2024 Effi […]<\/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\/25860"}],"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=25860"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25860\/revisions"}],"predecessor-version":[{"id":25861,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25860\/revisions\/25861"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}