Concomitant medication dataset in Pharmacokinetics of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children

Concomitant medication 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