Pharmacokinetics and Safety of Ceftobiprole in Pediatric Patients
Autor: | Rima Snariene, Hans Georg Münch, Anne Smits, Christopher M. Rubino, Arunas Liubsys, Karine Litherland, Tomasz Tomasik, Kamal Hamed, Dace Gardovska, Chi D. Hornik, Mark J Polak, Przemko Kwinta, Veerle Cossey, Sebastian Schröpf, Christine Ruehle, Miroslava Bosheva |
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Rok vydání: | 2021 |
Předmět: |
Data Analysis
Male PNEUMONIA cephalosporin Cephalosporin Phases of clinical research Pediatrics THERAPY Gastroenterology Medicine noncompartmental analysis Child Cross Infection pediatric patients Half-life SPECTRUM CEPHALOSPORIN BAL5788 Anti-Bacterial Agents Community-Acquired Infections Infectious Diseases Child Preschool ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Administration Intravenous Female Life Sciences & Biomedicine pharmacokinetics ceftobiprole Microbiology (medical) medicine.medical_specialty Adolescent medicine.drug_class Immunology Ceftobiprole DOSE PHARMACOKINETICS Antimicrobial Reports Microbial Sensitivity Tests Minimum inhibitory concentration Pharmacokinetics Internal medicine Humans Dosing Science & Technology business.industry Infant Newborn Infant Pneumonia PHARMACODYNAMICS medicine.disease Cephalosporins Pediatrics Perinatology and Child Health business |
Zdroj: | The Pediatric Infectious Disease Journal Pediatric infectious disease journal, Philadelphia : Lippincott Williams and Wilkins, 2021, vol. 40, no. 11, p. 997-1003 |
ISSN: | 0891-3668 1532-0987 |
Popis: | Supplemental Digital Content is available in the text. Background: Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation, broad-spectrum, intravenous cephalosporin, which is currently approved for the treatment of adults with hospital-acquired or community-acquired pneumonia. Methods: Noncompartmental pharmacokinetics and safety were analyzed from 2 recently completed pediatric studies, a single-dose, phase 1 study in neonates and infants up to 3 months of age (7.5 mg/kg) and a phase 3 study in patients 3 months to 17 years of age with pneumonia (10–20 mg/kg with a maximum of 500 mg per dose every 8 hours for up to 14 days). Results: Total ceftobiprole plasma concentrations peaked at the end of infusion. Half life (median ranging from 1.9 to 2.9 hours) and overall exposure (median AUC ranging from 66.6 to 173 μg•h/mL) were similar to those in adults (mean ± SD, 3.3 ± 0.3 hours and 102 ± 11.9 μg•h/mL, respectively). Calculated free-ceftobiprole concentrations in the single-dose study remained above a minimum inhibitory concentration (MIC) of 4 mg/L (fT > MIC of 4 mg/L) for a mean of 5.29 hours after dosing. In the pneumonia study, mean fT > MIC of 4 mg/L was ≥5.28 hours in all dose groups. Ceftobiprole was well tolerated in both studies. Conclusions: Pharmacokinetic parameters of ceftobiprole characterized in the pediatric population were within the range of those observed in adults. In the pneumonia study, the lowest percentage of the dosing interval with fT > MIC of 4 mg/L was 50.8%, which suggests that pharmacokinetic-pharmacodynamic target attainment can be sufficient in pediatric patients. Ceftobiprole was well tolerated. |
Databáze: | OpenAIRE |
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