{"id":64779,"date":"2022-05-26T23:36:02","date_gmt":"2022-05-26T21:36:02","guid":{"rendered":"https:\/\/www.fedaiisf.it\/?p=64779"},"modified":"2022-05-27T10:47:30","modified_gmt":"2022-05-27T08:47:30","slug":"antibiotico-resistenza","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/antibiotico-resistenza\/","title":{"rendered":"ANTIBIOTIC RESISTANCE"},"content":{"rendered":"<p>\u201cAntibiotic resistance is a global problem, it is a real pandemic that has been going on for years and will continue to go on for many years. Italy is one of the countries that is paying the greatest price. Suffice it to say that almost 11,000 people die every year in Italy due to infections due to multi-resistant germs and this, evidently, gives the dimension of the problem and its impact not only in terms of deaths, but also at an economic and public health level &quot; this is how Prof. Massimo Andreoni, scientific director of the infectious disease company SIMIT, defines the topic of antimicrobial resistance (AMR).<\/p>\n<p>\u201cThe literature highlights how the correct approach to antibiotic resistance is an approach that tackles the problem in all areas; therefore from environmental sanitation, to people&#039;s behavior, to what is the control of antibiotic therapy, without doing without adequate risk control&quot; continues Andreoni on the sidelines of the SIMIT 2021 Congress.<\/p>\n<p>In recent years, the difficulty caused by the lack of new antibiotics in treating infections with multi-resistant germs has been repeatedly reported.<a href=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2022\/05\/antibioticoresistenza-1024x904-1.jpeg\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-64788 alignright\" src=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2022\/05\/antibioticoresistenza-1024x904-1-300x265.jpeg\" alt=\"\" width=\"338\" height=\"299\" srcset=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2022\/05\/antibioticoresistenza-1024x904-1-300x265.jpeg 300w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2022\/05\/antibioticoresistenza-1024x904-1-768x678.jpeg 768w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2022\/05\/antibioticoresistenza-1024x904-1.jpeg 1024w\" sizes=\"auto, (max-width: 338px) 100vw, 338px\" \/><\/a><\/p>\n<p>As AMR is a global threat, regulators in the EU, the US and Japan have agreed to align their data requirements as much as possible so that developers of medicines can design clinical trials that meet the testing needs of multiple regulatory agencies. The revised document reflects the outcome of these discussions and also includes:<\/p>\n<ul>\n<li>clarification of recommended clinical development schedules for antimicrobials intended to address an unmet need;<\/li>\n<li>clinical trial guidelines to support the treatment of uncomplicated urinary tract infections and uncomplicated gonorrhea;<\/li>\n<li>updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics\u201d.<\/li>\n<\/ul>\n<p>The revised guidelines are published together with an addendum to guide the clinical development programs needed to support the authorization of medicines for the treatment of bacterial infections in children.<\/p>\n<p>Source:<\/p>\n<p><a href=\"https:\/\/www.simit.org\/\" target=\"_blank\" rel=\"noopener\">SIMIT -XX SIMIT Congress \u2013 Bacterial infections\u00a0<\/a><\/p>\n<p><a href=\"https:\/\/www.panoramasanita.it\/2022\/05\/26\/antibiotico-resistenza-dallema-le-linee-guida-per-lo-sviluppo-di-nuovi-antibiotici\/\" target=\"_blank\" rel=\"noopener\">Panorama of Healthcare \u2013 26 May 2022<\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-3_en.pdf\" target=\"_blank\" rel=\"noopener\">EMA \u2013 Guideline on the evaluation of medicinal products <\/a><br \/>\nindicated for treatment of bacterial infections -19 May 2022<\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address_en-0.pdf\" target=\"_blank\" rel=\"noopener\">EMA \u2013 Addendum to the guideline<\/a> on the evaluation of medicinal<br \/>\nproducts indicated for the treatment of bacterial infections to<br \/>\naddress pediatric-specific clinical data requirements \u2013 19 May 2022<\/p>\n<p>Related articles:<\/p>\n<p><a href=\"https:\/\/www.fedaiisf.it\/en\/giornata-europea-sulluso-consapevole-degli-antibiotici\/\" target=\"_blank\" rel=\"noopener\">Fedaiisf \u2013 18 Nov 2021 \u2013 European day on the conscious use of antibiotics<\/a><\/p>\n<p><a href=\"https:\/\/www.fedaiisf.it\/en\/ogni-assunzione-di-antibiotici-concorre-a-sviluppare-lantimicrobico-resistenza\/\" target=\"_blank\" rel=\"noopener\">Fedaiisf \u2013 3 Dec 2019 -Every use of antibiotics contributes to the development of antimicrobial resistance<\/a><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&#8220;L&#8217;antibiotico resistenza \u00e8 un problema globale, \u00e8 una vera e propria pandemia che sta andando avanti da anni e che continuer\u00e0 ad andare avanti per molti anni. L&#8217;Italia \u00e8 uno dei Paesi che sta pagando lo scotto maggiore. Basti pensare che ogni anno in Italia muoiono quasi 11.000 persone per colpa di infezioni dovute a &hellip;<\/p>","protected":false},"author":1,"featured_media":64781,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49,73],"class_list":["post-64779","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa","tag-batteri-farmacoresistenza"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/64779","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=64779"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/64779\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/64781"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=64779"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=64779"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=64779"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}