Skip to main content
Duke University Libraries
DukeSpace Scholarship by Duke Authors
  • Login
  • Ask
  • Menu
  • Login
  • Ask a Librarian
  • Search & Find
  • Using the Library
  • Research Support
  • Course Support
  • Libraries
  • About
View Item 
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
  •   DukeSpace
  • Duke Scholarly Works
  • Scholarly Articles
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.

Thumbnail
View / Download
841.5 Kb
Date
2018-09
Authors
Thaden, Joshua T
Chiswell, Karen
Jaffe, Ian
Bergin, Stephen P
Yang, William E
Romaine, Andrew
Roberts, Jamie
Nambiar, Sumathi
Farley, John
Benjamin, Daniel K
Smith, P Brian
Tsalik, Ephraim L
Show More
(12 total)
Repository Usage Stats
30
views
12
downloads
Abstract
BACKGROUND AND OBJECTIVES:The impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial or antifungal drug trials is unknown. Our objective was to identify and characterize trials conducted under the BPCA and/or the PREA. METHODS:Pediatric antibacterial and antifungal drug trials with industry or US federal funding registered in clinicaltrials.gov from 2007 to 2017 were identified. Those conducted under BPCA and/or PREA were identified through US Food and Drug Administration and National Institute of Child Health and Human Development databases. RESULTS:Of 17 495 pediatric trials registered on clinicaltrials.gov between October 2007 and September 2017, 122 systemic antibacterial or antifungal drug trials with industry or US federal funding were identified. Of these 122 trials, 98 (80%) involved antibacterials only, 23 (19%) antifungals only, and 1 (1%) both antibacterials and antifungals. These represented <1% (122 of 17 495) of pediatric trials. Neither pediatric antibacterial nor antifungal drug trials commonly enrolled neonates 0 to 30 days old (30% [30 of 99] vs 42% [10 of 24], respectively). Pediatric antibacterial and antifungal trials were commonly industry funded (79% [78 of 99] and 83% [20 of 24], respectively). In total, 65% (79 of 122) of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA. Researchers in trials conducted under BPCA and/or PREA, relative to non-BPCA and/or PREA trials, more often collected pharmacokinetic data (70% [55 of 79] vs 26% [11 of 43]). CONCLUSIONS:Although the majority of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA, the overall number was low. Greater effort is needed to stimulate such trials.
Type
Journal article
Subject
Humans
Communicable Diseases
Anti-Bacterial Agents
Antifungal Agents
Drug Industry
Child
United States
Clinical Trials as Topic
Permalink
https://hdl.handle.net/10161/21659
Published Version (Please cite this version)
10.1542/peds.2017-1849
Publication Info
Thaden, Joshua T; Chiswell, Karen; Jaffe, Ian; Bergin, Stephen P; Yang, William E; Romaine, Andrew; ... Tsalik, Ephraim L (2018). Pediatric Antibacterial and Antifungal Trials From 2007 to 2017. Pediatrics, 142(3). pp. e20171849-e20171849. 10.1542/peds.2017-1849. Retrieved from https://hdl.handle.net/10161/21659.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
Collections
  • Scholarly Articles
More Info
Show full item record

Scholars@Duke

Benjamin

Daniel Kelly Benjamin Jr.

Kiser-Arena Distinguished Professor
Dr. Danny Benjamin is the Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network. The Network is responsible for designing and leading clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The team has established, or is actively studying, the correct dosing and safety of more than 70 of the most commonly used medicines in children. E
Bergin

Stephen Patrick Bergin

Assistant Professor of Medicine
Chiswell

Karen Chiswell

Statistical Scientist
Ph.D., North Carolina State University - 2007I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linke
Smith

Phillip Brian Smith

Samuel L. Katz Distinguished Professor of Pediatrics
Dr. Smith completed his residency in pediatrics and a fellowship in neonatal medicine at Duke University Medical Center in 2004 and 2007, respectively. He completed an MHS in clinical research from Duke University in 2006 and an MPH in biostatistics from the University of North Carolina at Chapel Hill in 2009. His research is focused on pediatric drug safety, neonatal pharmacology, and the epidemiology of neonatal infections. Dr. Smith is or has been the protocol chair for more than 14 studie
Thaden

Joshua Thomas Thaden

Assistant Professor of Medicine
Tsalik

Ephraim Tsalik

Adjunct Associate Professor in the Department of Medicine
My research is focused on understanding the dynamic between host and pathogen so as to discover and develop host-response markers that can diagnose and predict health and disease.  This new and evolving approach to diagnosing illness has the potential to significantly impact individual as well as public health considering the rise of antibiotic resistance. With any potential infectious disease diagnosis, it is difficult, if not impossible, to determine at the time of presentation
More Authors
Alphabetical list of authors with Scholars@Duke profiles.
Open Access

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy

Rights for Collection: Scholarly Articles


Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info

Make Your Work Available Here

How to Deposit

Browse

All of DukeSpaceCommunities & CollectionsAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit DateThis CollectionAuthorsTitlesTypesBy Issue DateDepartmentsAffiliations of Duke Author(s)SubjectsBy Submit Date

My Account

LoginRegister

Statistics

View Usage Statistics
Duke University Libraries

Contact Us

411 Chapel Drive
Durham, NC 27708
(919) 660-5870
Perkins Library Service Desk

Digital Repositories at Duke

  • Report a problem with the repositories
  • About digital repositories at Duke
  • Accessibility Policy
  • Deaccession and DMCA Takedown Policy

TwitterFacebookYouTubeFlickrInstagramBlogs

Sign Up for Our Newsletter
  • Re-use & Attribution / Privacy
  • Harmful Language Statement
  • Support the Libraries
Duke University