Hello from PTN,
In what has been a whirlwind of a spring, the Pediatric Trials Network (PTN) has been afforded the opportunity to highlight our efficiencies and collaborative structure through the work we have contributed to the fight against COVID-19. Our expanded POP02 work will be instrumental in helping inform the decisions parents and healthcare providers make when caring for our youngest patients with COVID-19. I encourage you to read more about this via the link provided below.
Our work has also resulted in three recent label changes of caffeine, doxycycline, and clindamycin.
I hope you will check out
PTN's website
,
Facebook
page, and
Twitter
to stay on top of all the wonderful work being done by our investigators. I am thankful now, as much as ever, for all the contributions you make to
improving healthcare for our youngest world influencers.
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Danny Benjamin, MD, PhD, MPH
Pediatric Trials Network, Principal Investigator
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PTN Contributes to Fight Against COVID-19
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In record speed, the Pediatric Trials Network (PTN) worked to collaboratively and successfully stand up an extended component of the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02) to focus on six drugs that have the potential to be involved in the treatment of COVID-19. “Site investigators and staff are working extremely hard during a challenging time to...obtain data to guide frontline clinicians during a public health crisis such as what we are currently facing,” said Dr. Chi Hornik, POP02 Study Principal Investigator
The drugs that will be studied first are: Azithromycin, Chloroquine, Hydroxychloroquine, Lopinavir/Ritonavir, Ribavirin, and Tocilizumab. While the initial focus will begin with these six drugs, more drugs will be added soon.
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PTN Research Informs FDA Label Changes
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The Food and Drug Administration (FDA) recently approved
three
label changes, founded upon research provided by PTN. “With each label change, PTN is giving pediatricians more of the critical information they need to improve the lives of their patients and give parents more confidence in their children’s care,” said Kanecia Zimmerman, MD, associate professor of pediatrics at Duke University School of Medicine and Co-PI for the PTN.
Learn more about the Caffeine, Doxycycline, and Clindamycin label changes below:
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Recent PTN Publications
Puia-Dumitrescu M, Benjamin DK Sr, Smith PB, Greenberg RG, Abuzaid N, Andrews W, Chellani K, Gupta A, Price D, Williams C, Malcolm WF, Clark RH, Zimmerman KO
Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C
Puia-Dumitrescu M, Younge N, Benjamin DK, Lawson K, Hume C, Hill K, Mengistu J, Wilson A, Zimmerman ZO, Ahmad K, Greenberg RG; on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network
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NICHD News
NICHD, part of NIH, leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. This work includes funding important projects like PTN to fill gaps in research data. Learn more about the institute’s broad portfolio through
the NICHD website
.
Check out NICHD related information below:
Study Summaries Available
Part of the mandate of the Best Pharmaceuticals for Children Act (BPCA) is to prioritize needs in pediatric therapeutics, sponsor pediatric studies in those prioritized areas, and make study data available to investigators and the public. NICHD recently posted summaries from BPCA research to help inform clinicians about the progress that has been made in pediatric therapeutics. Summaries of study results on acyclovir, caffeine citrate, clindamycin, diazepam, doxycycline, lithium, and TMP-SMX are now available at
https://www.nichd.nih.gov/research/supported/bpca/resources/study-summaries.
New Funding Opportunity Announcement (FOA) Posted
NICHD recently posted the following FOA:
PAR-20-161: Catalyzing Innovation in Pediatric Pharmacology Clinical Trial Design and Resource Access (X01 Clinical Trial Not Allowed). The FOA aims to
provide investigators with access to a consultative resource for planning activities and concept development for clinical trials that address gaps in pediatric drug development and that align with priorities identified by BPCA. Pediatric drug development trials often require non-traditional designs with the opportunity to expand for novelty and/or innovation. Funded investigators will have access to the expertise in pediatric drug development trial designs through the consultative services provided by the Pediatric Trials Network and the BPCA Data Coordinating Center. For more information please visit
https://grants.nih.gov/grants/guide/pa-files/PAR-20-161.html
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Process for Sharing Data and Samples
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Interested in
Participating in PTN Studies?
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Currently enrolling:
Learn more about each study via the links below
Recruiting soon:
- Pharmacokinetics and Safety Profile of Terbutaline Sulfate in Children with Bronchospasm Secondary to Acute Severe Asthma Exacerbation (TBS)
- Safety, Preliminary Effectiveness, and Pharmacokinetics (PK) of Drugs in Infants (Preemie Platform)
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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.
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