Literature DB >> 33106262

FDA Public Workshop Summary: Advancing Animal Models for Antibacterial Drug Development.

James M Byrne1,2, Ursula Waack3,2, Edward A Weinstein3, Abhay Joshi4, Simone M Shurland3, Dmitri Iarikov3, Jürgen B Bulitta5, Binh An Diep6, Tina Guina7, William W Hope8, Matthew B Lawrenz9, Alexander J Lepak10, Brian M Luna11, Lynn Miesel12, Andrew J Phipps13, Thomas J Walsh14, William Weiss15, Thushi Amini3, John J Farley3.   

Abstract

The U.S. Food and Drug Administration (FDA) hosted a public workshop entitled "Advancing Animal Models for Antibacterial Drug Development" on 5 March 2020. The workshop mainly focused on models of pneumonia caused by Pseudomonas aeruginosa and Acinetobacter baumannii The program included discussions from academic investigators, industry, and U.S. government scientists. The potential use of mouse, rabbit, and pig models for antibacterial drug development was presented and discussed.
Copyright © 2020 American Society for Microbiology.

Entities:  

Keywords:  FDA; animal models; antibacterial; antibiotics; drug development; humanized dose; pneumonia; regulatory; workshop

Year:  2020        PMID: 33106262      PMCID: PMC7927847          DOI: 10.1128/AAC.01983-20

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN: 0066-4804            Impact factor:   5.191


  6 in total

1.  Ceftolozane-Tazobactam in the Treatment of Experimental Pseudomonas aeruginosa Pneumonia in Persistently Neutropenic Rabbits: Impact on Strains with Genetically Defined Mechanisms of Resistance.

Authors:  Vidmantas Petraitis; Ruta Petraitiene; Ethan Naing; Thein Aung; Wai Phyo Thi; Povilas Kavaliauskas; Bo Bo Win Maung; Adam O Michel; Rodolfo J Ricart Arbona; Andrew C DeRyke; Darren L Culshaw; David P Nicolau; Michael J Satlin; Thomas J Walsh
Journal:  Antimicrob Agents Chemother       Date:  2019-08-23       Impact factor: 5.191

2.  Pharmacokinetics and Efficacy of Ceftazidime-Avibactam in the Treatment of Experimental Pneumonia Caused by Klebsiella pneumoniae Carbapenemase-Producing K. pneumoniae in Persistently Neutropenic Rabbits.

Authors:  Ruta Petraitiene; Vidmantas Petraitis; Povilas Kavaliauskas; Bo Bo W Maung; Farehin Khan; Ethan Naing; Thein Aung; Vilma Zigmantaite; Ramune Grigaleviciute; Audrius Kucinskas; Rimantas Stakauskas; Benjamin N Georgiades; Chase A Mazur; Joshua A Hayden; Michael J Satlin; Thomas J Walsh
Journal:  Antimicrob Agents Chemother       Date:  2020-03-24       Impact factor: 5.191

3.  Development and evaluation of murine lung-specific disease models for Pseudomonas aeruginosa applicable to therapeutic testing.

Authors:  Matthew B Lawrenz; Ashley E Biller; Daniel E Cramer; Jennifer L Kraenzle; Julie B Sotsky; Carol D Vanover; Deborah R Yoder-Himes; Angela Pollard; Jonathan M Warawa
Journal:  Pathog Dis       Date:  2015-04-09       Impact factor: 3.166

Review 4.  Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia.

Authors:  Ursula Waack; Edward A Weinstein; John J Farley
Journal:  Antimicrob Agents Chemother       Date:  2020-04-21       Impact factor: 5.191

5.  Murine Oropharyngeal Aspiration Model of Ventilator-associated and Hospital-acquired Bacterial Pneumonia.

Authors:  Travis B Nielsen; Jun Yan; Brian Luna; Brad Spellberg
Journal:  J Vis Exp       Date:  2018-06-28       Impact factor: 1.355

6.  Natural history of Acinetobacter baumannii infection in mice.

Authors:  Brian M Luna; Jun Yan; Zeferino Reyna; Eugene Moon; Travis B Nielsen; Hernan Reza; Peggy Lu; Robert Bonomo; Arnold Louie; George Drusano; Jürgen Bulitta; Rosemary She; Brad Spellberg
Journal:  PLoS One       Date:  2019-07-18       Impact factor: 3.240

  6 in total
  3 in total

1.  Pseudomonas aeruginosa Ventilator-Associated Pneumonia Rabbit Model for Preclinical Drug Development.

Authors:  Nhu T Q Nguyen; Emmanuelle Gras; Nguyen D Tran; Nhi N Y Nguyen; Hanh T H Lam; William J Weiss; Thien N M Doan; Binh An Diep
Journal:  Antimicrob Agents Chemother       Date:  2021-06-17       Impact factor: 5.191

2.  Histopathological Analysis of Acinetobacter baumannii Lung Infection in a Mouse Model.

Authors:  Shigeru Tansho-Nagakawa; Yoshinori Sato; Tsuneyuki Ubagai; Takane Kikuchi-Ueda; G O Kamoshida; Satoshi Nishida; Yasuo Ono
Journal:  Pol J Microbiol       Date:  2021-12-23

3.  The utilization of Blaptica dubia cockroaches as an in vivo model to test antibiotic efficacy.

Authors:  Elliot Collins; Caleb Martin; Tyler Blomquist; Katherine Phillips; Stuart Cantlay; Nathan Fisher; Joseph Horzempa
Journal:  Sci Rep       Date:  2021-12-14       Impact factor: 4.996

  3 in total

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