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February 8, 2022 | SIDERO-CR-2014/2016

SIDERO-CR-2014/2016 Program
Conducted by Shionogi
Active:
2014 to 2016 (completed)

Studies: 1

Countries: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovenia, Spain, Sweden, Turkey, UK, Argentina, Brazil, Chile, Colombia, Dominican Republic, Guatemala, Mexico, Panama, Puerto Rico, Venezuela, Canada, USA, Japan, South Korea, Malaysia, Pakistan, Singapore, Taiwan, Thailand, Vietnam, Australia, New Zealand, Philippines, Kenya, South Africa, Georgia, Jordan, Kuwait

Primary objective
Evaluation of cefiderocol activity against carbapenem-resistant isolates from global countries.

Protocol Summary

Isolates collection method:From IHMA 2014-2016 surveillance study frozen stock culture collection.
Types of surveillance:Routine clinical practice then used for surveillance.
Methodology and breakpoints:MICs of cefiderocol have been determined by broth microdilution assay using iron-depleted cation-adjusted Mueller-Hinton broth, which has been approved by CLSI and EUCAST. MICs of other comparators have been determined by broth microdilution assay using cation-adjusted Mueller-Hinton broth, which has been approved by CLSI and EUCAST. The breakpoints of comparators were based on published information by CLSI and EUCAST.
Inclusion and exclusion criteria:Isolates of Enterobacteriacea were chosen based on their carbapenem-non-susceptible phenotype (meropenem MIC of ≥2 μg/ml). Isolates of A. baumannii and P. aeruginosa were chosen as multi-drug-resistant phenotype (amikacin-resistant (MIC, ≥32 μg/ml), ciprofloxacin-resistant (MIC, ≥4 μg/ml), and meropenem-resistant (MIC, ≥16 μg/ml). Isolates of S. maltophilia (N = 217) and B. cepacia (N = 4) were chosen based solely on their identities and the preponderance of each of these species to demonstrate MDR phenotypes.
Date Last Updated
Contains pediatric data?
Contains genotype data?
List of publications to be linked In Vitro Activity of the Siderophore Cephalosporin, Cefiderocol, against Carbapenem-Nonsusceptible and Multidrug-Resistant Isolates of Gram-Negative Bacilli Collected Worldwide in 2014 to 2016
Any additional information