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Cefiderocol

Generic Name
Cefiderocol
Brand Names
Fetroja, Fetcroja
Drug Type
Small Molecule
Chemical Formula
C30H34ClN7O10S2
CAS Number
1225208-94-5
Unique Ingredient Identifier
SZ34OMG6E8
Background

Cefiderocol is a cephalosporin antibacterial drug and exerts a mechanism of action similar to other β-lactam antibiotics. Unlike other agents in this category, cefiderocol is a siderophore able to undergo active transport into the bacterial cell through iron channels. It represents a significant addition to antibacterial treatment option as it has proven to be effective in vitro against multidrug resistant strains including extended spectrum β-lactamase producers and carbapenemase producing bacteria.

Cefiderocol was granted designation as a Qualified Infectious Disease Product and granted priority review status by the FDA on November 14, 2019. It is indicated for use in complicated urinary tract infections in patients with limited or no alternative treatments available. This indication was supported by a positive clinical trial composed of 448 patients with complicated urinary tract infections which demonstrated a 72.6% rate of symptom resolution and bacterial eradication with cefiderocol compared to 54.6% with the comparator, imipenem/cilastatin. A concern noted in the trial was a 0.3% higher rate of all cause mortality, the cause of which has not been determined.

Indication

Cefiderocol is indicated for the treatment of complicated urinary tract infections with or without pyelonephritis.

Associated Conditions
Complicated Urinary Tract Infection, Nosocomial Pneumonia, Pyelonephritis, Ventilator Associated Bacterial Pneumonia (VABP)
Associated Therapies
-

RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

Phase 2
Completed
Conditions
Bloodstream Infections
Interventions
Other: Best Available Therapy
Drug: Cefiderocol
First Posted Date
2019-03-11
Last Posted Date
2024-02-13
Lead Sponsor
The University of Queensland
Target Recruit Count
513
Registration Number
NCT03869437
Locations
🇸🇬

National University Hospital Singapore, Singapore, Singapore

🇦🇺

Westmead Hospital, Sydney, New South Wales, Australia

🇦🇺

Royal Brisbane and Womens Hospital, Brisbane, Queensland, Australia

and more 16 locations

Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia

Phase 1
Terminated
Conditions
Bacterial Pneumonia
Interventions
Drug: Cefiderocol
Drug: Standard of Care Antibiotic
First Posted Date
2019-03-05
Last Posted Date
2020-11-05
Lead Sponsor
Shionogi
Target Recruit Count
7
Registration Number
NCT03862040
Locations
🇺🇸

Hartford Hospital, Hartford, Connecticut, United States

🇺🇸

North Western University, Chicago, Illinois, United States

🇺🇸

Weill Cornell Medical College, New York, New York, United States

and more 4 locations

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Conditions
Bacterial Infections
First Posted Date
2018-12-19
Last Posted Date
2020-02-28
Lead Sponsor
Shionogi
Registration Number
NCT03780140

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

Phase 3
Completed
Conditions
Healthcare-associated Pneumonia (HCAP)
Ventilator Associated Pneumonia (VAP)
Hospital Acquired Pneumonia (HAP)
Interventions
First Posted Date
2017-01-26
Last Posted Date
2020-11-13
Lead Sponsor
Shionogi
Target Recruit Count
300
Registration Number
NCT03032380
Locations
🇺🇦

Shionogi Research Site, Zaporizhzhya, Ukraine

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

Phase 3
Completed
Conditions
Hospital Acquired Pneumonia (HAP)
Complicated Urinary Tract Infection (cUTI)
Ventilator Associated Pneumonia (VAP)
Healthcare-associated Pneumonia (HCAP)
Sepsis
Bloodstream Infections (BSI)
Interventions
Drug: Best Available Therapy
Drug: Cefiderocol
First Posted Date
2016-03-21
Last Posted Date
2021-01-12
Lead Sponsor
Shionogi
Target Recruit Count
152
Registration Number
NCT02714595
Locations
🇬🇧

Shionogi Research Site, London, England, United Kingdom

A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections

Phase 2
Completed
Conditions
Urinary Tract Infections
Interventions
Drug: Imipenem/cilastatin
Drug: Cefiderocol
First Posted Date
2014-12-22
Last Posted Date
2019-12-12
Lead Sponsor
Shionogi
Target Recruit Count
452
Registration Number
NCT02321800
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