Study Description

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.

Publications

• Systemic Timolol Exposure Following Topical Application to Infantile Hemangiomas
  Journal of the American Academy of Dermatology • February 2019 Access article on PubMed. Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee. Off-label ophthalmic timolol has been rapidly adopted for treatment of infantile hemangioma since topical application of beta-blockers was presumed to have an improved safety profile ...
• A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data
  Journal of Pharmacokinetics and Pharmacodynamics • June 2018 Access article on PubMed. Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. Amiodarone is a first-line antiarrhythmic for life-threatening ventricular fibrillation or ventricular tachycardia in children, yet little ...
• Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children
  The Journal of Clinical Pharmacology • April 2018 Access article on PubMed. Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Ketamine is an N-methyl D-aspartate receptor antagonist used off-label to facilitate ...
• Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates
  Therapeutic Drug Monitoring • February 2018 Access article on PubMed. Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to ...
• Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children
  Antimicrobial Agents and Chemotherapy • December 2017 Access article on PubMed. Autmizguine J, Melloni C, Hornik CP, Dallefeld S, Harper B, Yogev R, Sullivan JE, Atz AM, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D; the Pediatric Trials Network Steering Committee. Trimethoprim (TMP)-sulfamethoxazole (SMX) is used to treat various types ...
• Respiratory Support for Very Low Birth Weight Infants Receiving Dexamethasone
  The Journal of Pediatrics • April 2017 Access article on PubMed. Virkud YV, Hornik CP, Benjamin DK, Laughon MM, Clark RH, Greenberg RG, Smith PB. To assess how neonatal intensive care units followed the American Academy of Pediatrics guidelines for use of dexamethasone in preterm infants by evaluating respiratory support at the time of dexamethasone administration. This is ...
• Pharmacokinetics of Clindamycin in Obese and Nonobese Children
  Antimicrobial Agents and Chemotherapy • March 2017 Access article on PubMed. Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Although obesity is prevalent among children in the United States, pharmacokinetic ...
• Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates
  Journal of Pediatrics • August 2016 Access article on PubMed. Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act—Pediatric Trials Network. This was a retrospective observational cohort study of electronic health record (EHR) data combined with pharmacokinetic model derived drug exposure predictions. We ...
• Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants
  Antimicrobial Agents and Chemotherapy • April 2016 Access article on PubMed. Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin may be active against methicillin-resistant Staphylococcus aureus, a common pathogen causing sepsis in infants, but optimal dosing ...
• Use and Safety of Erythromycin and Metoclopramide in Hospitalized Infants
  Journal of Pediatric Gastroenterology and Nutrition • August 2015 Access article on PubMed. Ericson JE, Arnold C, Cheeseman J, Cho J, Kaneko S, Wilson E, Clark RH, Benjamin DK Jr, Chu V, Smith PB, Hornik CP; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee. Prokinetic medications are used in premature infants to promote motility and decrease ...
• Rifampin use and safety in hospitalized infants
  American Journal of Perinatology • May 2015 Access article on PubMed. Arnold CJ, Ericson J, Kohman J, Corey KL, Oh M, Onabanjo J, Hornik CP, Clark RH, Benjamin DK Jr, Smith PB, Chu VH; Best Pharmaceuticals for Children Act–Pediatric Trials Network Administrative Core Committee. This study aims to examine the use and safety of rifampin in hospitalized infants. ...
• Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots
  Bioanalysis • May 2015 Access article on PubMed. 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. Trimethoprim-sulfamethoxazole (TMP-SMX) is an antimicrobial drug combination commonly prescribed ...
• Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents
  Clinical Pharmacology and Therapeutics • September 2014 Access article on PubMed. 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; Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. Clindamycin is commonly prescribed ...
• Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design
  Antimicrobial Agents and Chemotherapy • June 2014 Access article on PubMed. Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Although ampicillin is the most commonly used ...