{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T01:34:10Z","timestamp":1790213650359,"version":"4.1.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2019,10,5]],"date-time":"2019-10-05T00:00:00Z","timestamp":1570233600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100009947","name":"Merck Sharp & Dohme Corp.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009947","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004334","name":"Merck & Co., Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009947","name":"Merck Sharp & Dohme Corp.","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":[[2020,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Investigate the efficacy of caspofungin in participants &amp;lt;3\u2009months of age with invasive Candida infection (ICI).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This multicentre, randomized, double-blind, comparator-controlled, Phase 2 study (protocol MK0991-064; NCT01945281) enrolled participants &amp;lt;3\u2009months of age with culture-confirmed ICI within 96\u2009h of study entry. Participants were randomly assigned 2:1 to once-daily intravenous 2\u2009mg\/kg caspofungin or intravenous 1\u2009mg\/kg amphotericin B deoxycholate (dAMB). The primary endpoint was fungal-free survival (FFS) 2\u2009weeks after treatment in the full-analysis-set (FAS) population, defined as participants with culture-confirmed ICI who received \u22651 dose of therapy. Planned enrolment was 90 participants.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Fifty-one participants were enrolled; 49 received treatment (caspofungin, n=33; dAMB, n=16); 2 additional participants did not have confirmed infections at study entry. The study was terminated after \u223c\u200a3.5\u2009years because of low enrolment. Forty-seven participants were included in the FAS population (caspofungin, n=31; dAMB, n=16). FFS rate at 2\u2009weeks after treatment was 71.0% (22\/31) in the caspofungin arm and 68.8% (11\/16) in the dAMB arm [difference, stratified by weight, \u2212\u200a0.9% (95% CI, \u2212\u200a24.3%\u201327.7%)]. Adverse events developed in 84.8% (28\/33) of participants in the caspofungin arm and 100% (16\/16) in the dAMB arm.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Among neonates and infants with confirmed ICI, FFS at 2\u2009weeks was similar in the caspofungin and dAMB treatment arms. A smaller proportion of participants who received caspofungin experienced adverse events.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkz398","type":"journal-article","created":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:10:57Z","timestamp":1569888657000},"page":"215-220","source":"Crossref","is-referenced-by-count":24,"title":["A randomized, double-blind trial investigating the efficacy of caspofungin versus amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants younger than 3\u2009months of age"],"prefix":"10.1093","volume":"75","author":[{"given":"Jason","family":"Kim","sequence":"first","affiliation":[{"name":"Merck & Co., Inc, Kenilworth, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Firdose Lambey","family":"Nakwa","sequence":"additional","affiliation":[{"name":"Chris Hani Baragwanath Academic Hospital, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South 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