Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (PTN POPS)

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.

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).

Publications

Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots.
Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee.
Bioanalysis • May 2015, volume 7, issue 9, pages 1137-149.
PMCID: PMC4455038 [Free access available on 5/1/2016]

Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents.
Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M.
Clinical Pharmacology and Therapeutics • October 2014, volume 96, issue 4, pages 429-437.
PMCID: PMC4169790 [Free PMC article]

Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.
Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Chong SI, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; on behalf of the Administrative Core Committee of the Best Pharmaceuticals for Children Act — Pediatric Trials Network.
Antimicrobial Agents and Chemotherapy • June 2014, volume 58, issue 6, pages 3013-3020.
PMCID: PMC3904301 [Free PMC article]

 

OVERVIEW

Status:
Enrolling

ClinicalTrials.gov identifier:
NCT01431326

Principal Investigator:
Chiara Melloni, MD, MHS
Duke Health, Durham, NC

NEWS

  • POPS Paradigm Explained August 25, 2016 PTN studies managed via the POPS paradigm seek to determine the appropriate dosing of understudied drugs in children by using samples collected as part of regular care (for example, blood draws). The data collected provides valuable pharmacokinetic and dosing information for drugs in different pediatric age groups and special pediatric populations (such as obese children). Dr. ...
  • A POPS site goes above and beyond October 14, 2014 For an example of an outstanding PTN site, look no further than Ann & Robert H. Lurie Children’s Hospital of Chicago. The top enrolling site for the POPS study, Lurie Children’s has enrolled 244 patients as of September 22. To put this number into perspective, the second highest enrolling POPS site has recruited 117 patients, ...
  • The POPS study grows by leaps and bounds February 1, 2013 The POPS study is moving full steam ahead. In September 2012, the study received additional funding from the National Institute of Child Health and Human Development to effectively double in size, increasing the number of patients enrolled from 500 to ~1000 and doubling the number of participating sites from ~15 to ~30. And the new year ...