Pediatric Antibacterial and Antifungal Trials From 2007 to 2017

Pediatrics
Joshua T ThadenEphraim L Tsalik

Abstract

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. 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. 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% [2...Continue Reading

References

Nov 18, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·John S Bradley, George H McCracken
Nov 28, 2008·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Helen W BoucherJohn Bartlett
May 3, 2012·JAMA : the Journal of the American Medical Association·Robert M CaliffAsba Tasneem
Jul 25, 2014·Clinical Pharmacology and Therapeutics·S NambiarE Cox
Oct 1, 2014·Pediatric Research·Lawrence C Ku, P Brian Smith
Jul 5, 2016·The Lancet Infectious Diseases·Laura FolgoriMike Sharland

❮ Previous
Next ❯

Citations

Jul 6, 2019·Open Forum Infectious Diseases·Ian S JaffeEphraim L Tsalik
Feb 2, 2021·Clinical Pharmacology and Therapeutics·Silke GastineJoseph F Standing
Jun 10, 2021·Journal of the Pediatric Infectious Diseases Society·Daniel K YeohBrendan J McMullan

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

© 2022 Meta ULC. All rights reserved