Summary

The Pediatric Trials Network (PTN) Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) study expands upon the work done as part of PTN POP01 study, to continue to shrink the gap between pediatric and adult data available to clinicians and families for therapeutics used in children.

The goal is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. 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. POP02 is a master protocol that will help provide valuable information for therapeutics used in special populations, such as critically ill children receiving ECMO or CRRT, premature infants, children with Down Syndrome, and children with obesity.

“This study and what we collectively learn through collaboration with site investigators and staff will be instrumental in helping inform the decisions parents and healthcare providers make when caring for children.” said Dr. Chi Hornik, POP02 Study Principal Investigator.

At the onset of the COVID-19 pandemic, POP02 expanded to include a substudy, called POP02-COVID, that would collect real-time COVID-19 related data in children affected by acute COVID-19 and multisystem inflammatory syndrome in children (MIS-C). POP02-COVID also supports the treatment of younger COVID-19 patients by evaluating several therapeutics to potentially treat COVID-19 patients age 0 – <21 years old.

“We will evaluate biomarkers, genetics, and outcomes of a comparator arm of SARS-CoV-2 positive participants not receiving one of the COVID-19 drugs of interest.  We do not have sufficient safety or efficacy data on many therapeutics used in children, and this is more critical during a time such as what we are currently facing,” said Hornik.

To learn more about POP02, visit the study listing on Clinicaltrials.gov.