Literature DB >> 27626768

Regulatory Pathways for New Antimicrobial Agents: Trade-offs to Keep the Perfect From Being the Enemy of the Good.

B Spellberg1,2, K A Marr3, E P Brass4.   

Abstract

In 2002, Shlaes and Moellering warned that pharmaceutical companies were abandoning antibiotic research and development due to changing regulatory standards regarding noninferiority (NI) clinical trials. NI trials are subject to unique biases that may yield false-positive conclusions. The US Food and Drug Administration (FDA) developed guidance to ensure that NI results truly reflect drug efficacy. These changes, intended to reduce uncertainty in trial results, have shaped trial enrollment and conduct in ways that now require reflection.
© 2016, ASCPT.

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Year:  2016        PMID： 27626768      PMCID： PMC5242400          DOI： 10.1002/cpt.510

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  9 in total

1.  The United States Food and Drug Administration and the end of antibiotics.

Authors:  David M Shlaes; Robert C Moellering
Journal:  Clin Infect Dis       Date:  2002-02-01       Impact factor: 9.079

2.  White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.

Authors: 
Journal:  Clin Infect Dis       Date:  2012-08-13       Impact factor: 9.079

3.  Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI).

Authors:  Florian M Wagenlehner; Obiamiwe Umeh; Judith Steenbergen; Guojun Yuan; Rabih O Darouiche
Journal:  Lancet       Date:  2015-04-27       Impact factor: 79.321

Review 4.  Isavuconazole: A New Broad-Spectrum Triazole Antifungal Agent.

Authors:  Marisa H Miceli; Carol A Kauffman
Journal:  Clin Infect Dis       Date:  2015-07-15       Impact factor: 9.079

Review 5.  Antibacterial drug development: challenges, recent developments, and future considerations.

Authors:  S Nambiar; K Laessig; J Toerner; J Farley; E Cox
Journal:  Clin Pharmacol Ther       Date:  2014-08       Impact factor: 6.875

6.  Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis.

Authors:  Francisco M Marty; Luis Ostrosky-Zeichner; Oliver A Cornely; Kathleen M Mullane; John R Perfect; George R Thompson; George J Alangaden; Janice M Brown; David N Fredricks; Werner J Heinz; Raoul Herbrecht; Nikolai Klimko; Galina Klyasova; Johan A Maertens; Sameer R Melinkeri; Ilana Oren; Peter G Pappas; Zdeněk Ráčil; Galia Rahav; Rodrigo Santos; Stefan Schwartz; J Janne Vehreschild; Jo-Anne H Young; Ploenchan Chetchotisakd; Sutep Jaruratanasirikul; Souha S Kanj; Marc Engelhardt; Achim Kaufhold; Masanori Ito; Misun Lee; Carolyn Sasse; Rochelle M Maher; Bernhardt Zeiher; Maria J G T Vehreschild
Journal:  Lancet Infect Dis       Date:  2016-03-09       Impact factor: 25.071

7.  Ceftolozane/Tazobactam Plus Metronidazole for Complicated Intra-abdominal Infections in an Era of Multidrug Resistance: Results From a Randomized, Double-Blind, Phase 3 Trial (ASPECT-cIAI).

Authors:  Joseph Solomkin; Ellie Hershberger; Benjamin Miller; Myra Popejoy; Ian Friedland; Judith Steenbergen; Minjung Yoon; Sylva Collins; Guojun Yuan; Philip S Barie; Christian Eckmann
Journal:  Clin Infect Dis       Date:  2015-02-10       Impact factor: 9.079

8.  Efficacy and Safety of Ceftazidime-Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-abdominal Infection: Results From a Randomized, Controlled, Double-Blind, Phase 3 Program.

Authors:  John E Mazuski; Leanne B Gasink; Jon Armstrong; Helen Broadhurst; Greg G Stone; Douglas Rank; Lily Llorens; Paul Newell; Jan Pachl
Journal:  Clin Infect Dis       Date:  2016-03-08       Impact factor: 9.079

9.  Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program.

Authors:  Florian M Wagenlehner; Jack D Sobel; Paul Newell; Jon Armstrong; Xiangning Huang; Gregory G Stone; Katrina Yates; Leanne B Gasink
Journal:  Clin Infect Dis       Date:  2016-06-16       Impact factor: 9.079
  9 in total
  1 in total

1.  Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities.

Authors:  Thomas M File; Elizabeth Alexander; Lisa Goldberg; Anita F Das; Christian Sandrock; Susanne Paukner; Gregory J Moran
Journal:  BMC Pulm Med       Date:  2021-05-08       Impact factor: 3.317
  1 in total

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