{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:08:42Z","timestamp":1792454922716,"version":"4.5.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2019,11,27]],"date-time":"2019-11-27T00:00:00Z","timestamp":1574812800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009947","name":"Merck Sharp and Dohme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,12,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Fidaxomicin, a narrow-spectrum antibiotic approved for Clostridioides (Clostridium) difficile infection (CDI) in adults, is associated with lower rates of recurrence than vancomycin; however, pediatric data are limited. This multicenter, investigator-blind, phase 3, parallel-group trial assessed the safety and efficacy of fidaxomicin in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients aged &amp;lt;18 years with confirmed CDI were randomized 2:1 to 10 days of treatment with fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, 4 times daily). Safety assessments included treatment-emergent adverse events. The primary efficacy end point was confirmed clinical response (CCR), 2 days after the end of treatment (EOT). Secondary end points included global cure (GC; CCR without CDI recurrence) 30 days after EOT (end of study; EOS). Plasma and stool concentrations of fidaxomicin and its active metabolite OP-1118 were measured.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 148 patients randomized, 142 were treated (30 &amp;lt;2 years old). The proportion of participants with treatment-emergent adverse events was similar with fidaxomicin (73.5%) and vancomycin (75.0%). Of 3 deaths in the fidaxomicin arm during the study, none were CDI or treatment related. The rate of CCR at 2 days after EOT was 77.6% (76 of 98 patients) with fidaxomicin and 70.5% (31 of 44) with vancomycin, whereas the rate of GC at EOS was significantly higher in participants receiving fidaxomicin (68.4% vs 50.0%; adjusted treatment difference, 18.8%; 95% confidence interval, 1.5%\u201335.3%). Systemic absorption of fidaxomicin and OP-1118 was minimal, and stool concentrations were high.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared with vancomycin, fidaxomicin was well tolerated and demonstrated significantly higher rates of GC in children and adolescents with CDI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT02218372<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciz1149","type":"journal-article","created":{"date-parts":[[2019,11,26]],"date-time":"2019-11-26T15:12:48Z","timestamp":1574781168000},"page":"2581-2588","source":"Crossref","is-referenced-by-count":81,"title":["Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with\n                    <i>Clostridioides (Clostridium) difficile<\/i>\n                    Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE)"],"prefix":"10.1093","volume":"71","author":[{"given":"Joshua","family":"Wolf","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases, St. Jude Children\u2019s Research Hospital, Memphis, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina","family":"Kalocsai","sequence":"additional","affiliation":[{"name":"Gyermekinfektol\u00f3gia, D\u00e9l-pesti Centrumk\u00f3rh\u00e1z Orsz\u00e1gos Haematol\u00f3giai \u00e9s Infektol\u00f3giai Int\u00e9zet, Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Fortuny","sequence":"additional","affiliation":[{"name":"Department of Paediatric Infectious Diseases, Hospital Sant Joan de D\u00e9u, Universitat de Barcelona, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Lazar","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Clinical Hospital for Infectious and Tropical Diseases \u201cDr. Victor Babe\u0219,\u201d Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Bosis","sequence":"additional","affiliation":[{"name":"Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Universit\u00e0 degli Studi di Milano, Fondazione IRCCS Ca\u2019 Granda Ospedale Maggiore Policlinico, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bartosz","family":"Korczowski","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Pediatric Gastroenterology, University of Rzesz\u00f3w, Rzesz\u00f3w, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Petit","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology, H\u00f4pital Trousseau, HUEP, APHP, Paris, France"},{"name":"Faculty of Medicine, Sorbonne Universit\u00e9, UMRS 938, GRC MyPAC, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Bradford","sequence":"additional","affiliation":[{"name":"Astellas Pharma B.V., Leiden, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney","family":"Croos-Dabrera","sequence":"additional","affiliation":[{"name":"Astellas Pharma Development, Northbrook, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elodie","family":"Incera","sequence":"additional","affiliation":[{"name":"Astellas Pharma B.V., Leiden, the 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