{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,26]],"date-time":"2025-12-26T14:51:07Z","timestamp":1766760667615,"version":"3.41.2"},"reference-count":33,"publisher":"American Society for Microbiology","issue":"11","license":[{"start":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T00:00:00Z","timestamp":1700006400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2023,11,15]],"date-time":"2023-11-15T00:00:00Z","timestamp":1700006400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100008323","name":"Cumberland Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100008323","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2023,11,15]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>Antimicrobial resistance increases infection morbidity in both adults and children, necessitating the development of new therapeutic options. Telavancin, an antibiotic approved in the United States for certain bacterial infections in adults, has not been examined in pediatric patients. The objectives of this study were to evaluate the short-term safety and pharmacokinetics (PK) of a single intravenous infusion of telavancin in pediatric patients. Single-dose safety and PK of 10 mg\/kg telavancin was investigated in pediatric subjects &gt;12 months to \u226417 years of age with known or suspected bacterial infection. Plasma was collected up to 24-h post-infusion and analyzed for concentrations of telavancin and its metabolite for noncompartmental PK analysis. Safety was monitored by physical exams, vital signs, laboratory values, and adverse events following telavancin administration. Twenty-two subjects were enrolled: 14 subjects in Cohort 1 (12\u201317 years), 7 subjects in Cohort 2 (6\u201311 years), and 1 subject in Cohort 3 (2\u20135 years). A single dose of telavancin was well-tolerated in all pediatric age cohorts without clinically significant effects. All age groups exhibited increased clearance of telavancin and reduced exposure to telavancin compared to adults, with mean peak plasma concentrations of 58.3 \u00b5g\/mL (Cohort 1), 60.1 \u00b5g\/mL (Cohort 2), and 53.1 \u00b5g\/mL (Cohort 3). A 10 mg\/kg dose of telavancin was well tolerated in pediatric subjects. Telavancin exposure was lower in pediatric subjects compared to adult subjects. Further studies are needed to determine the dose required in phase 3 clinical trials in pediatrics.<\/jats:p>","DOI":"10.1128\/aac.00987-23","type":"journal-article","created":{"date-parts":[[2023,10,10]],"date-time":"2023-10-10T13:01:06Z","timestamp":1696942866000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":4,"title":["Pharmacokinetics and safety of a single dose of telavancin in pediatric subjects 2\u201317 years of age"],"prefix":"10.1128","volume":"67","author":[{"given":"John S.","family":"Bradley","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of California San Diego School of Medicine and Rady Children\u2019s Hospital , San Diego, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer L.","family":"Goldman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Missouri-Kansas City and Children\u2019s Mercy Hospital , Kansas City, Missouri, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura P.","family":"James","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Arkansas Children\u2019s Hospital Research Institute , Little Rock, Arkansas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Byron","family":"Kaelin","sequence":"additional","affiliation":[{"name":"Product Development, Cumberland Pharmaceuticals Inc. , Nashville, Tennessee, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2196-8219","authenticated-orcid":false,"given":"Breanne H. 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Vancomycin flushing syndrome, p 1\u20131. https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK482506."},{"key":"e_1_3_5_24_2","doi-asserted-by":"publisher","DOI":"10.3390\/pharmacy8020070"},{"key":"e_1_3_5_25_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02475-17"},{"key":"e_1_3_5_26_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-020-03072-y"},{"key":"e_1_3_5_27_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12941-022-00529-z"},{"key":"e_1_3_5_28_2","doi-asserted-by":"publisher","DOI":"10.2217\/fmb.15.53"},{"key":"e_1_3_5_29_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-021-00468-w"},{"key":"e_1_3_5_30_2","doi-asserted-by":"publisher","DOI":"10.1080\/14787210.2023.2182769"},{"key":"e_1_3_5_31_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0260539"},{"key":"e_1_3_5_32_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00895-21"},{"key":"e_1_3_5_33_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofy209.125"},{"key":"e_1_3_5_34_2","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011422812"},{"key":"e_1_3_5_35_2","unstructured":"FDA CDER\n. 2022. General clinical pharmacology considerations for pediatric studies of drugs including biological products. Guidance for industry clinical pharmacology revision 1 contains nonbinding recommendations. 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