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Related Experiment Video

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Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant

Matteo Bassetti1,2, Mari Ariyasu3, Bruce Binkowitz4

  • 1Infectious Diseases Clinic, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Integrata, Udine, Italy.

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|December 11, 2019
PubMed
Summary

The CREDIBLE-CR study evaluated cefiderocol, a novel antibiotic, for treating carbapenem-resistant Gram-negative infections. This pathogen-focused trial provided descriptive evidence on cefiderocol

Keywords:
best available therapycarbapenem resistancecefiderocolpathogen-focused study designrapid diagnosticsstreamlined/limited clinical development

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Area of Science:

  • Infectious Diseases
  • Clinical Pharmacology
  • Antimicrobial Resistance

Background:

  • Carbapenem-resistant (CR) Gram-negative infections pose a significant unmet medical need.
  • Developing new antibiotics for CR infections faces challenges due to infection-site-specific drug approval pathways.
  • Novel therapeutic strategies are crucial to combat the rising threat of multidrug-resistant pathogens.

Purpose of the Study:

  • To evaluate the efficacy and safety of cefiderocol in patients with CR Gram-negative infections.
  • To provide descriptive evidence for a novel siderophore cephalosporin targeting difficult-to-treat pathogens.
  • To assess cefiderocol's potential in a pathogen-focused clinical development program.

Main Methods:

  • A randomized, open-label, Phase 3 study (CREDIBLE-CR) involving patients with CR Gram-negative infections.
  • Patients received either cefiderocol or the best available therapy (BAT) in a 2:1 ratio.
  • Utilized rapid diagnostic testing to identify CR pathogens and facilitate enrollment across various infection sites.

Main Results:

  • The study enrolled patients with infections caused by various CR Gram-negative pathogens, including Enterobacteriaceae and non-fermenters.
  • Descriptive data on cefiderocol's efficacy and safety were collected.
  • The sample size was determined by enrollment feasibility, not statistical power.

Conclusions:

  • The CREDIBLE-CR study represents a significant pathogen-focused trial for a new antibiotic against CR infections.
  • It provides valuable descriptive evidence to support cefiderocol's role in treating infections caused by challenging Gram-negative pathogens.
  • The study design addresses regulatory expectations for novel antimicrobial development in the context of antimicrobial resistance.