Pharmacodynamics of Meropenem and Tobramycin for Neonatal Meningoencephalitis: Novel Approaches to Facilitate the Development of New Agents to Address the Challenge of Antimicrobial Resistance

Author:

Farrington Nicola1,McEntee Laura1,Johnson Adam1,Unsworth Jennifer1,Darlow Christopher1ORCID,Jimenez-Valverde Ana1,Hornik Christoph2,Greenberg Rachel3,Schwartz Julie4,Das Shampa1ORCID,Hope William1ORCID

Affiliation:

1. Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool, Liverpool, United Kingdom

2. Division of Pediatric Critical Care Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina, USA

3. Division of Neonatal-Perinatal Medicine, Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina, USA

4. Charles River Laboratories, Davis, California, USA

Abstract

Neonatal sepsis is an underrecognized burden on health care systems throughout the world. Antimicrobial drug resistance (AMR) is increasingly prevalent and compromises the use of currently recommended first-line agents.

Funder

HHS | U.S. Food and Drug Administration

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Reference18 articles.

1. Effects of antibiotic resistance, drug target attainment, bacterial pathogenicity and virulence, and antibiotic access and affordability on outcomes in neonatal sepsis: an international microbiology and drug evaluation prospective substudy (BARNARDS)

2. A Phase 3 Study of Micafungin Versus Amphotericin B Deoxycholate in Infants With Invasive Candidiasis

3. Pull Incentives for Antibacterial Drug Development: An Analysis by the Transatlantic Task Force on Antimicrobial Resistance

4. Agency EM. 2006. European Community. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of medicinal products for paediatric use amended by Regulation (EC) No 1902/2006. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1902&from=EN.

5. Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans; guidance for industry. 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pediatric-study-plans-content-and-process-submitting-initial-pediatric-study-plans-and-amended.

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