A Message from the Lead Principal Investigator
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Since our last POST was released, there have been a number of exciting developments at the Pediatric Trials Network (PTN). In addition to enrolling patients in several studies, including long-term antipsychotic use and commonly used drugs passed through breast milk, PTN research has helped inform a drug label change for acyclovir and a fluconazole update published in
Red Book.
In this POST issue, you will also find information regarding the LAPS Trial and the upcoming Pediatric Academic Societies (PAS) Meeting, as well as a spotlight on Dr. Christine Turley, who has been heavily involved in the PTN POPS study. We are thankful to everyone involved in the PTN. The hard work
of many
enables us to continue our mission of informing formulation, dosing, efficacy, and safety of drugs, as well as medical devices, used in pediatric patients. We look forward to an exciting and productive 2019!
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Danny Benjamin, MD, PhD, MPH
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PTN Research Informs FDA Label Change
Research conducted by the PTN has led the U.S. Food and Drug Administration (FDA) to update the prescribing information, or drug label, of acyclovir to include dosing for infants with Neonatal Herpes Simplex Virus (HSV) based upon the infants' post-menstrual age. Acyclovir (brand name Zovirax) is an antiviral drug used to treat HSV, a highly contagious virus that can be very serious for babies.
Learn more about the label change here.
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Red Book Updated Based on PTN Study
The American Academy of Pediatrics (AAP) has updated the 2018 edition of the
Red Book
to include fluconazole dosing information determined by a PTN study. The changes were based on a study conducted from 2008 to 2011 that analyzed safety data on the use of fluconazole to treat infections caused by the Candida yeast. The
Red Book
is the leading resource on pediatric infectious disease, providing the most up-to-date information on a wide variety of diseases that doctors see in children.
Read more about the update.
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PTN Featured in AAP News
The AAP recently spotlighted the work being done by the PTN. The article, written by
Perdita Taylor-Zapata of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and P. Brian Smith of the PTN and the Duke Department of Pediatrics, explains how the PTN generates data to help regulators update drug labels for safer and more effective use of medications in infants and children.
Learn more and read the full article.
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PTN LAPS Trial Activates Sites
The two-year LAPS study, led by Dr. Linmarie Sikich (right) of the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine, will follow children aged 3 to 17 who are already taking an antipsychotic (risperidone or aripiprazole) to treat disorders such as schizophrenia, bipolar disorder, and irritability associated with autism. Five sites have been activated so far.
Read more about the LAPS Trial.
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PAS Save the Date
Mark your calendar now! The PTN will host an educational symposium on Sunday, April 28, at 7:30 p.m. at the Pediatric Academic Societies (PAS) Meeting in Baltimore, Md. The symposium is titled, “Clinical Research in the Pediatric Population: A Network Perspective.” PAS will take place April 24 - May 1 this year. Don’t miss your opportunity to attend the leading event for academic pediatrics and child health research.
Register for PAS here
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and stay tuned for more details!
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Spotlight on Dr. Christine Turley, University of South Carolina
Dr. Christine Turley currently serves as director of the Research Center for Transforming Health at the University of South Carolina and is involved in the administration of the Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (PTN POPS) study. We recently sat down with Dr. Turley to gain her insights on the importance of PTN POPS and pediatric clinical research as a whole.
Read the complete interview
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We want your stories!
If your involvement in PTN has had an impact on you, your career, or your care for patients, we want to hear from you. Please send an email to
[email protected]
to share your story. We may feature it on our website and in an upcoming newsletter!
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Recruiting soon:
- Pharmacokinetics and Safety Profile of Digoxin in Infants with Single Ventricle Congenital Heart Disease
Currently enrolling:
- Pharmacokinetics and Safety of Anesthetics and Analgesics in Children and Adolescents (ANA)
- Long-term Antipsychotic Pediatric Safety Trial (LAPS)
- Pharmacokinetics of Anti-epileptic Drugs in Obese Children (AED)
- Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (POPS)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE)
- Efficacy, Pharmacokinetics, and Safety of Topical Timolol in Infants with Infantile Hemangioma
- Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia
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