Oral Amoxicillin and Cephalexin PK/PD in Neonates

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 1, 2021

Keywords

ClinConnect Summary

This proposal's objective is to evaluate the pharmacokinetics and pharmacodynamics (PK/PD) of enteral amoxicillin and cephalexin in neonates and young infants admitted to the hospital, characterize age-stratified PK/PD parameters, and use these data to improve neonatal antibiotic dosing strategies. This will involve developing and validating small-volume sampling assays using dried blood spots. The study hypothesizes that there will be significant inter-individual variation in amoxicillin and cephalexin PK/PD parameters in neonates and that delayed absorption and elimination will lead to lo...

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Eligibility criteria

• Inclusion Criteria:
• * Patients admitted to Children's Hospital Colorado derived from two groups:
• • Group 1-patients specifically receiving enteral amoxicillin (with or without clavulanate) or cephalexin for any clinical indication;
• • Group 2-patients receiving any IV antibiotic who are tolerating full enteral feeds and/or enteral medications.
• Exclusion Criteria:
• • Across both groups, exclusion criteria are: (1) weight \<2kg, (2) renal dysfunction, including the use of any renal replacement therapy, (3) significant β-lactam allergy, (4) GI disorders significantly impairing drug absorption, (5) use of external circuits that would affect the study drug's volume of distribution (e.g. ECMO), and (6) clinically significant anemia precluding study-related blood draws.