{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:11:19Z","timestamp":1792681879679,"version":"4.5.0"},"reference-count":36,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,4,19]],"date-time":"2025-04-19T00:00:00Z","timestamp":1745020800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This phase 2a study evaluated pharmacokinetics and safety of ceftazidime-avibactam (CAZ\/AVI; combination dosed as fixed 4:1 ratio) in neonates and young infants with suspected\/confirmed infections due to Gram-negative pathogens requiring intravenous antibiotics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Hospitalized neonates and infants (gestational age\u2005\u2265\u200526 weeks to\u2005&amp;lt;\u20053 months), enrolled sequentially into 3 age cohorts, received CAZ\/AVI single dose (Part A) or multiple dose every 8\u00a0h (Part B) by 2-h intravenous infusions. Infants\u2005&amp;gt;\u200528 days (Cohort 1) received CAZ\/AVI 37.5\u00a0mg\/kg\/dose (CAZ 30\u00a0mg\/kg and AVI 7.5\u00a0mg\/kg). Full-term neonates\u2005\u2264\u200528 days (Cohort 2) and preterm neonates\u2005\u2264\u200528 days (Cohort 3) received 25\u00a0mg\/kg\/dose (CAZ 20\u00a0mg\/kg and AVI 5\u00a0mg\/kg). Pharmacokinetics, safety, and clinical and microbiological outcomes (Part B only) were assessed descriptively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty-six patients received CAZ\/AVI, 25 in Part A and 21 in Part B. Sepsis (39.1%) and urinary tract infection (15.2%) were the predominant diagnoses. Observed drug plasma-concentration time profiles were generally similar across cohorts. Overall, 23 patients (50%) had\u2005\u2265\u20051 adverse event (AE), 8 patients (17.4%) had\u2005\u2265\u20051 serious AE (SAE), and 2 patients (4.3%) died; no SAE or death was treatment related. In Part B,\u2005\u2265\u200580% of patients had favorable clinical and microbiological responses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Plasma exposures after single and multiple CAZ\/AVI doses in neonates and young infants\u2005&amp;lt;\u20053 months old (37.5 [30\/7.5] mg\/kg\/dose for\u2005&amp;gt;\u200528 days; 25 [20\/5] mg\/kg\/dose for\u2005\u2264\u200528 days) were similar to approved doses for older children. The safety profile of CAZ\/AVI was as expected based on previous observations.<\/jats:p>\n                    <jats:p>Study funded by Pfizer. Trial registration: NCT04126031.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jpids\/piaf028","type":"journal-article","created":{"date-parts":[[2025,4,17]],"date-time":"2025-04-17T05:40:47Z","timestamp":1744868447000},"source":"Crossref","is-referenced-by-count":11,"title":["Pharmacokinetics and Safety of Ceftazidime-Avibactam in Neonates and Young Infants: A Phase 2a, Multicenter Prospective Trial"],"prefix":"10.1093","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3835-5064","authenticated-orcid":false,"given":"John","family":"Bradley","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Rady Children\u2019s Hospital, University of California San Diego School of Medicine , San Diego, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Roilides","sequence":"additional","affiliation":[{"name":"3rd Department of Pediatrics, Aristotle University and Hippokration Hospital , Thessaloniki 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