{"id":25051,"date":"2022-06-10T16:16:16","date_gmt":"2022-06-10T15:16:16","guid":{"rendered":"https:\/\/ppr-antibioresistance.inserm.fr\/?p=25051"},"modified":"2022-06-10T16:16:20","modified_gmt":"2022-06-10T15:16:20","slug":"phagotherapie-lansm-autorise-un-acces-compassionnel-pour-des-bacteriophages-dans-les-infections-osteo-articulaires","status":"publish","type":"post","link":"https:\/\/ppr-antibioresistance.inserm.fr\/en\/informations-et-communications\/actualites\/phagotherapie-lansm-autorise-un-acces-compassionnel-pour-des-bacteriophages-dans-les-infections-osteo-articulaires\/","title":{"rendered":"Phagoth\u00e9rapie : l\u2019ANSM autorise un acc\u00e8s compassionnel pour des bact\u00e9riophages dans les infections ost\u00e9o-articulaires"},"content":{"rendered":"\n<p>Article publi\u00e9 sur le site de l&#8217;ANSM le 09 juin 2022<\/p>\n\n\n\n<p>Afin de permettre aux patients qui ne peuvent pas participer \u00e0 un essai clinique d\u2019acc\u00e9der \u00e0 la phagoth\u00e9rapie dans un cadre s\u00e9curis\u00e9, nous autorisons d\u00e9sormais l\u2019acc\u00e8s compassionnel (AAC) \u00e0 deux bact\u00e9riophages anti-<em>Staphylococcus aureus<\/em>&nbsp;(PP1493 et PP1815), pour le traitement d\u2019infections osseuses et ost\u00e9o-articulaires graves document\u00e9es \u00e0&nbsp;<em>Staphylococcus aureus<\/em>.<\/p>\n\n\n\n<p>Les bact\u00e9riophages sont des virus qui pourraient repr\u00e9senter une approche compl\u00e9mentaire \u00e0 l\u2019antibioth\u00e9rapie pour traiter des patients en impasse th\u00e9rapeutique dans le contexte pr\u00e9occupant de l\u2019antibior\u00e9sistance. En effet, ils poss\u00e8dent la particularit\u00e9 d\u2019infecter uniquement des bact\u00e9ries et leur utilisation \u00e0 vis\u00e9e th\u00e9rapeutique repose sur un m\u00e9canisme de lyse bact\u00e9rienne. Des essais cliniques doivent toutefois \u00eatre men\u00e9s pour apporter la d\u00e9monstration de leur efficacit\u00e9.<br>A ce jour, aucun m\u00e9dicament contenant des bact\u00e9riophages ne dispose d&#8217;autorisation de mise sur le march\u00e9 (AMM) dans l\u2019Union europ\u00e9enne ni aux Etats-Unis.<\/p>\n\n\n\n<p>Dans ce contexte, nous avons autoris\u00e9 l\u2019essai clinique PhagoDAIR I qui devrait prochainement d\u00e9buter et d\u2019autres essais cliniques viendront compl\u00e9ter cette recherche.<\/p>\n\n\n\n<p>Les essais cliniques et les autorisations d\u2019acc\u00e8s compassionnel peuvent \u00eatre mis en place car ces bact\u00e9riophages sont d\u00e9sormais produits et contr\u00f4l\u00e9s selon les standards de qualit\u00e9 \u00e9quivalents \u00e0 ceux requis pour tous les m\u00e9dicaments exp\u00e9rimentaux.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Dans quelles situations ces bact\u00e9riophages anti-<em>Staphylococcus aureus<\/em>&nbsp;(PP1493 et PP1815) peuvent-ils \u00eatre utilis\u00e9s ?<\/h4>\n\n\n\n<p>Ces deux bact\u00e9riophages sont indiqu\u00e9s chez l\u2019adulte et l\u2019adolescent dans le traitement des infections osseuses et ost\u00e9o-articulaires graves document\u00e9es \u00e0<em>\u00a0Staphylococcus aureus<\/em>, lorsque le pronostic vital ou fonctionnel est engag\u00e9, et en situation d\u2019impasse th\u00e9rapeutique, en application locale ou en injection\u00a0<em>in situ<\/em>.\u00a0<\/p>\n\n\n\n<p>Le recours aux bact\u00e9riophages dans le cadre de l\u2019AAC pourra \u00eatre consid\u00e9r\u00e9 pour des patients qui ne peuvent pas participer \u00e0 un essai clinique (PhagoDAIR I \u00e9tant le seul essai clinique autoris\u00e9 en France \u00e0 ce jour).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Quelles sont les conditions \u00e0 respecter ?<\/h4>\n\n\n\n<p>L\u2019utilisation de ces bact\u00e9riophages est r\u00e9serv\u00e9e \u00e0 l\u2019usage hospitalier et soumise \u00e0 une proc\u00e9dure de surveillance \u00e9troite de la part de l\u2019ANSM par le biais d\u2019un protocole d\u2019utilisation th\u00e9rapeutique et de recueil de donn\u00e9es d\u2019utilisation et de s\u00e9curit\u00e9.<a href=\"https:\/\/ansm.sante.fr\/uploads\/2022\/06\/09\/20220609-aac-put-pp1493-pp1815-2022-05-19-2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Consulter le PUT d\u2019AAC Bact\u00e9riophages anti-Staphylococcus aureus PP1493, solution injectable et Bact\u00e9riophages anti-Staphylococcus aureus PP1815, solution injectable (09\/06\/2022)<\/a><\/p>\n\n\n\n<p>Chaque demande de prescription devra \u00eatre valid\u00e9e par un avis coll\u00e9gial donn\u00e9 par un centre de r\u00e9f\u00e9rence des infections ost\u00e9o-articulaires complexes (Crioac). Cela tiendra compte du r\u00e9sultat d\u2019un phagogramme qui est \u00e0 r\u00e9aliser obligatoirement pour tester l\u2019activit\u00e9 de chaque bact\u00e9riophage sur la bact\u00e9rie responsable de l\u2019infection.A savoirLes CRIOAC, compos\u00e9s d\u2019\u00e9quipes pluridisciplinaires sp\u00e9cialis\u00e9s dans la prise en charge des infections ost\u00e9o-articulaires, sont r\u00e9partis sur tout le territoire national. <\/p>\n\n\n\n<p>Ils seront les garants de la validation th\u00e9rapeutique des demandes d\u2019ACC de bact\u00e9riophages.Les bact\u00e9riophages PP1493 et PP1815 devront \u00eatre utilis\u00e9s en association pour limiter le risque de r\u00e9sistance. Des donn\u00e9es en vie r\u00e9elle seront recueillies pour enrichir le suivi et les connaissances sur ces m\u00e9dicaments.\u00a0<\/p>\n\n\n\n<p><a href=\"https:\/\/ansm.sante.fr\/tableau-atun\/bacteriophages-anti-staphylococcus-aureus-pp1493-solution-injectable-bacteriophages-anti-staphylococcus-aureus-pp1815-solution-injectable\" target=\"_blank\" rel=\"noreferrer noopener\">Consultez la fiche d&#8217;autorisation d&#8217;acc\u00e8s compassionel pour les bact\u00e9riophages PP1493 et PP1815<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Article publi\u00e9 sur le site de l&#8217;ANSM le 09 juin 2022 Afin de permettre aux patients qui ne peuvent pas participer \u00e0 un essai clinique d\u2019acc\u00e9der \u00e0 la phagoth\u00e9rapie dans un cadre s\u00e9curis\u00e9, nous autorisons d\u00e9sormais l\u2019acc\u00e8s compassionnel (AAC) \u00e0 deux bact\u00e9riophages anti-Staphylococcus aureus&nbsp;(PP1493 et PP1815), pour le traitement d\u2019infections osseuses et ost\u00e9o-articulaires graves document\u00e9es [&hellip;]<\/p>\n","protected":false},"author":139,"featured_media":25057,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[31],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - 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