Issue 42 | December 2023

Hello from the PTN,

The end of 2023 is rapidly approaching! The conclusion of another year brings the opportunity to reflect on our work and chart a path forward. Thank you to all who are involved with the Pediatric Trials Network (PTN), without whom the year’s accomplishments would not be possible. Your continued dedication has made this another year to celebrate. Keep an eye out for the 2022-2023 Annual Review, which will highlight all the year’s accomplishments. In this edition of the PTN Post, we provide an overview of the PTN’s activities in quarter four of 2023.

The Network enrolled the first participants in its study evaluating how healthy adults process methadone. The results from this trial will lay the groundwork for pediatric clinical research on methadone. Additionally, Data from PTN research was used to update the CDC’s guidelines around anthrax treatment and prevention.

We talked with Dr. Susan Rahman about her experiences in pediatric care and what PTN’s work means to her.

In 2023, research by the PTN informed two U.S. Food and Drug Administration (FDA) drug label changes, for levetiracetam and rifampin. To date, the PTN has contributed data to 19 FDA drug label changes. Going into the new year, The PTN continues to study pediatric care and medicines with seven active clinical trials, and two enrolling soon. Read on to learn more about all these accomplishments.

The entire PTN leadership team wishes you a safe and restful holiday and New Year season with loved ones. Thank you again for your support.

Sincerely,

First participants enrolled in methadone study for adults

The PTN has enrolled the first participants in Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02). This study is evaluating how healthy adults process methadone administered through IV. Methadone is already approved by the FDA for pain management in adults. Results from MTH02 will help update information on dosing methadone for adults, and they will lay the foundation for studies to label methadone for treating acute pain for children.

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Dr. Susan Rahman is a member of the PTN Steering Committee. In her spotlight, she shares her experience improving the health of underserved groups and how it applies to her work on the PTN Diversity Metrics Team.

“Our recent implementation research has been particularly rewarding. We are developing solutions that empower parents and community health workers to improve the health and wellbeing of children in their homes and villages. Not only have we observed a measurable impact on child health, but we’ve heard directly from families about how meaningful these tools have been to them. It’s easy to forget that almost half of the world’s population doesn’t have access to basic health services, so developing practical and sustainable solutions to address these gaps is incredibly satisfying.”

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The U.S. Centers for Disease Control and Prevention (CDC) recently updated its guidelines for the prevention and treatment of naturally occurring anthrax. Data from PTN studies are cited for recommended dosages of medicines like clindamycin and meropenem.

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Clindamycin 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 PTN’s studies of the antibiotic clindamycin. These studies were needed to determine the safety of clindamycin for treating infections like methicillin-resistant Staphylococcus aureus (MRSA) for children aged from infancy to adolescence.

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

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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

READ MORE ABOUT BPCA

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.

• A Prospective, Blinded, Cross-Over Trial of the Exposure-Response Relationship of Terbutaline Sulfate in Adults with Asthma (TBS02)
• Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02)
• Anesthetics and Analgesics in Children (ANA)
• Commonly used drugs during lactation and infant exposure (CUDDLE)
• Long-term Antipsychotic Pediatric Safety Trial (LAPS)
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02)
• Safety of Sildenafil in Premature Infants (Sildenafil II)

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.