Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Benjamin
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); OpAns, LLC; The Emmes Company, LLC; The EMMES Corporation
• Treatments: Alfentanil; Amikacin; Aminocaproic Acid; Aripiprazole; Bosentan; Cefepime; Cidofovir; Ciprofloxacin; Clozapine; Fosfomycin; Haloperidol; Hydroxocobalamin; Labetalol; Levofloxacin; Lurasidone Hydrochloride; Methylprednisolone; Metoclopramide; Molindone; Nafcillin; Nifedipine; Norepinephrine; Oxycodone; Pentobarbital; Piperacillin; Piperacillin, Tazobactam Drug Combination; Rocuronium; Sevelamer; Spironolactone; Tazobactam; Tobramycin; Tranexamic Acid; Valproic Acid; Vancomycin; Warfarin; Ziprasidone; Zolpidem

Criteria

Inclusion Criteria:

• 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

• 1) Failure to obtain consent/assent (as indicated)

• 2) Known pregnancy as determined via interview or testing if available.