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Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients.
- Source :
-
Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2016 Sep 23; Vol. 60 (10), pp. 6252-9. Date of Electronic Publication: 2016 Sep 23 (Print Publication: 2016). - Publication Year :
- 2016
-
Abstract
- This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK study was conducted in pediatric patients hospitalized with an infection and receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 to <18 years; cohort 2, ≥6 to <12 years; cohort 3, ≥2 to <6 years; cohort 4, ≥3 months to <2 years). Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg]; cohorts 3 and 4, 50 to 12.5 mg/kg). Blood samples were collected to describe individual PK characteristics for ceftazidime and avibactam. Population PK modeling was used to describe characteristics of ceftazidime and avibactam PK across all age groups. Safety and tolerability were assessed. Thirty-two patients received study drug. Mean plasma concentration-time curves, geometric mean maximum concentration (Cmax), and area under the concentration-time curve from time zero to infinity (AUC0-∞) were similar across all cohorts for both drugs. Six patients (18.8%) reported an adverse event, all mild or moderate in intensity. No deaths or serious adverse events occurred. The single-dose PK of ceftazidime and avibactam were comparable between each of the 4 age cohorts investigated and were broadly similar to those previously observed in adults. No new safety concerns were identified. (This study has been registered at ClinicalTrials.gov under registration no. NCT01893346.).<br /> (Copyright © 2016 Bradley et al.)
- Subjects :
- Adolescent
Azabicyclo Compounds adverse effects
Ceftazidime adverse effects
Child
Child, Preschool
Drug Combinations
Female
Hospitals, Pediatric
Humans
Infant
Male
Azabicyclo Compounds administration & dosage
Azabicyclo Compounds pharmacokinetics
Ceftazidime administration & dosage
Ceftazidime pharmacokinetics
beta-Lactamase Inhibitors administration & dosage
beta-Lactamase Inhibitors pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 1098-6596
- Volume :
- 60
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Antimicrobial agents and chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 27503642
- Full Text :
- https://doi.org/10.1128/AAC.00862-16