Phase 2 study of the safety, pharmacokinetics and efficacy of ceftaroline fosamil in neonates and very young infants with late-onset sepsis
The Pediatric Infectious Disease Journal Mar 05, 2020
Bradley JS, Stone GG, Chan PLS, et al. - Researchers conducted this phase 2, open-label, multicenter study to test the safety and effectiveness of ceftaroline fosamil in late-onset sepsis (LOS). Eligible neonates and very young infants 7 to < 60 days of age with LOS were enrolled and received ceftaroline fosamil 4 or 6 mg/kg every 8 hours by 1-hour intravenous infusion plus intravenous ampicillin and optional aminoglycoside for 48 hours−14 days. Eleven individuals [median (range) age 24 (12–53) days] were recruited and received ceftaroline fosamil for a median (range) duration of 8 (3–15) days. Diarrhea was the most frequent adverse event in this analysis. Safety has been consistent with the known ceftaroline fosamil safety profile in neonates and very young infants. Such findings support the use of ceftaroline fosamil (6 mg/kg every 8 hours) as a potential option for LOS treatment.
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