Codelists, combinded codelists, and system codelists dataset in Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children

Codelists, combinded codelists, and system codelists dataset
Study Description
Failure to account for childhood physiological changes can lead to improper dosing which is associated with decreased drug efficacy & safety. Population physiologically-based pharmacokinetic (PBPK) modeling helps predict optimal dosing based on physiologic parameters adjusted for developmental changes. PBPK models are mathematical constructs that use physiologic processes, drug characteristics & genetic variances to characterize dose-exposure relationships across the age continuum. Models integrate drug-specific & systems-specific info to predict effects of different factors (e.g., age, disease) on drug exposure. PBPK models can reduce the number of children needed for trials & maximize dose-based safety/efficacy. This trial evaluated a platform to validate PBPK models in children using Clindamycin & Bactrim, both among the most commonly used agents to treat gram-positive infections in children, and ideal candidates to evaluate PBPK models due to differing physico-chemical properties & elimination pathways. Children requiring prophylaxis or treatment of infection with either: Clindamycin as intravenous (IV) formulation with transition to oral (PO) formulation permissible & ages =1 month to <17 yrs or TMP-SMX as oral formulation & ages =2 months and <17 yrs