PTN Post | Issue 41

Issue 41 | September 2023

Hello from the PTN,

We’re already over halfway through 2023 and fall is around the corner. As school and work get back into full swing, the Pediatric Trials Network (PTN) is providing updates on what we’ve done since the last edition of the PTN Post.

The PTN reached a huge milestone – the 19th label change informed by PTN research. Two PTN studies contributed data to update the U.S. Food and Drug Administration (FDA) label of levetiracetam, an anti-epileptic. Researchers studied how pediatric patients with obesity process the drug, and how this information should be considered when clinicians prescribe it.

The PTN continues to evaluate medications for safety and efficacy in children. Several new medicines have been added to those being tested by the CUDDLE study, which is examining the safety of medicines passed to infants through breastmilk.

Over the summer, two members of the PTN traveled to California to present at the International Children’s Advisory Network (iCAN) Annual Summit. They presented what the PTN does, and how we work with iCAN to improve pediatric clinical research and care.

Two new PTN studies have opened: A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma (TBS02) and Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02). Both of these studies are testing treatments in adults that will inform future research in pediatric patients. Two more studies will open to enrollment soon. Additionally, the PTN shared a new results-at-a-glance summary about the antibiotic metronidazole. Learn more about all this work in the newsletter below

Thank you to everyone who has made these accomplishments possible, especially research participants and their families. We look forward to continuing to research and inform the safest and most effective pediatric care.

Danny Benjamin, MD, PhD, MPH

Pediatric Trials Network, Principal Investigator

Rachel Greenberg, MD, MB, MHS

Pediatric Trials Network, Steering Committee Chair

Research by the PTN informs levetiracetam label change

The PTN studies Pharmacokinetics of Anti-epileptic Drugs in Obese Children (AED01) and Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (POP01) contributed data on the anti-epileptic medicine levetiracetam and how a pediatric patient’s obesity status should be considered by prescribers when determining its dosage. This information was used to change the FDA label which contains dosage information. This information is essential for clinicians to keep in mind when prescribing levetiracetam.

Additional drugs being assessed by CUDDLE study

The PTN trial Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE) has added new medications to be studied. With this addition, the team is eager to expand the effort to understand the safety of medications passed through breastmilk. CUDDLE is now gathering data on these additional medicines:

Amoxicillin
Bupropion
Buprenorphine
Duloxetine
Hydrocodone
Levetiracetam
Paroxetine

PTN team presents at iCAN Summit

In July, members of the PTN had the opportunity to attend, participate, and present at the 2023 International Children’s Advisory Network (iCAN) Summit in La Jolla, California. Government Trials Associate Director, Phyllis Kennel, and Research Communications and Engagement Specialist, Meagan Daly, presented to a group of young people and industry representatives. The presentation familiarized them with the work of the PTN and Duke Clinical Research Institute Pediatrics. The presentation also provided updates on the ways in which iCAN participation has helped inform the work of PTN, like the development of a pediatric anthology that includes pediatric patients’ reflections on their experience with pediatric clinical care and research studies.

Metronidazole results-at-a-glance

The PTN works to make medications and medical devices safer and more effective for all children. As part of that work, we share what we learn with research participants and the general public through results-at-a-glance summaries. The most recently completed summary was on the antibiotic metronidazole. This study was needed to determine the safety of metronidazole for treating infants with complicated intra-abdominal infections. Metronidazole was determined to be safe and effective in this group of infants.

Keep an eye on the Results-at-a-Glance webpage for more study summaries as they are completed.

PTN label changes to date

Under the Best Pharmaceuticals for Children Act (BPCA), the PTN provides the FDA with information to inform drug label changes with the information needed to prescribe the most appropriate doses of the medications to children. As a result of research conducted through the BPCA program the following label changes have been made:

Acyclovir
Ampicillin
Caffeine
Clindamycin (x2)
Diazepam
Doxycycline
Levetiracetam
Lisinopril
Lithium
Lorazepam
Mercy babyTAPE
2D Mercy TAPE
3D Mercy TAPE
Meropenem
Propylthiouracil
Pralidoxime
Rifampin
Sodium nitroprusside

PTN studies currently enrolling:

PTN has seven ongoing studies, six of which are enrolling and one in the follow-up phase. Click the links below to learn more about each study.

PTN studies recruiting soon:

Guanfacine for Hyperactivity in Children with Down Syndrome (HYP01)
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (BMS02)

Useful PTN links:

The PTN Publication Policy lays out the process of PTN publication writing and review, required information, and the role of the PTN Publication Committee.
In an effort to share data with other researchers, PTN provides access to its analytical methods for evaluating drugs in several matrices including plasma, dried blood spots, urine, cerebral spinal fluid, and breastmilk. View the methods and request access to data.

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PTN is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and provides pediatricians, researchers, and regulators with new information on how children respond to medications.