Determining the appropriate dosing of several understudied drugs in children using samples collected as part of regular care.

This study will characterize the pharmacokinetics of understudied drugs that are administered to children regularly by their treating physicians. Approximately 3000 children, less than 21 years of age, are participating in the study for up to 90 days (depending on how long the drug of interest is being dosed). The Pediatric Trials Network hopes to generate data to shrink the gap between pediatric and adult dosing information available to prescribing physicians for their pediatric patients. View study data for ampicillin opportunistic/PK, doxycycline opportunistic/PK, methadone opportunistic/PK, ondansetron opportunistic/PK, or trimethoprim- sulfamethoxazole (Bactrim) opportunistic/PK on NICHD's Data and Specimen Hub (DASH).

Micky Cohen-Wolkowiez, MD, PhD, of the Duke Clinical Research Institute, discusses the PTN POPS study.

Summary

Many drugs prescribed in Asia, Europe and North America lack specific dosing recommendations for children. These gaps in information about pediatric drug dosing, safety, and efficacy place children at risk for adverse events and therapeutic failure.

Earlier studies relying on standard-of-care procedures have successfully characterized the pharmacokinetics (i.e., what the body does to the drug) of drugs used in children. These studies did not actually administer drugs to children but rather collected samples from children who were already receiving the drugs as part of standard medical care.

Similarly, in this study, understudied drugs are being administered to children by their treating physicians according to local standards of care. The only study procedure involves biological sample collection during the time of drug administration. Approximately 3000 children aged <21 years who are receiving these drugs are being enrolled and will be followed for up to 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 study. By taking advantage of procedures done as part of routine medical care (for example, blood draws), this study will provide better understanding of drug exposure in children. The data collected will also provide valuable pharmacokinetic and dosing information for drugs in different pediatric age groups, as well as special pediatric populations (such as obese children).

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