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Cefiderocol

DRUG20 trials

Sponsors

Centre Hospitalier Universitaire De Nimes, Shionogi, The University of Queensland, Joseph L. Kuti, PharmD, Hartford Hospital

Conditions

Acinetobacter BacteremiaAcinetobacter PneumoniaAerobic Gram-negative Bacterial Infections Complicated urinary tract infection (cUTI) Complicated intra-abdominal infection (cIAI) Hospital-acquired bacterial pneumonia (HABP) Ventilator-associated (VABP) Bloodstream infection (BSI)/sepsisBacterial InfectionsBacterial PneumoniaBloodstream InfectionBloodstream InfectionsBloodstream Infections (BSI)

Phase 1

Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
TerminatedNCT03862040
ShionogiBacterial Pneumonia
Start: 2019-02-20End: 2019-10-15Updated: 2020-11-05
Cefiderocol PK in Patients on ECMO
CompletedNCT04995835
Joseph L. Kuti, PharmDSepsis
Start: 2021-07-16End: 2024-09-01Updated: 2024-12-16
Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy
CompletedNCT05373615
Hartford HospitalPharmacokinetics
Start: 2022-07-25End: 2024-11-20Updated: 2024-12-18
A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
CompletedNCT05395104
ShionogiHealthy Volunteers
Start: 2022-05-24End: 2022-07-13Updated: 2023-12-14
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
CompletedNCT06547554
Qpex Biopharma, Inc.Bacterial Infections
Start: 2024-09-04End: 2025-10-27Updated: 2025-11-28

Phase 2

A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections
CompletedNCT02321800
ShionogiUrinary Tract Infections
Start: 2015-02-05End: 2016-08-16Updated: 2019-12-12
RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI
CompletedNCT03869437
The University of QueenslandBloodstream Infections
Start: 2019-10-28End: 2024-01-29Updated: 2024-02-13
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
CompletedNCT04215991
ShionogiComplicated Urinary Tract Infection (cUTI), Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP) +1
Start: 2020-02-19End: 2024-09-17Updated: 2025-05-25
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
CompletedNCT04335539
ShionogiBloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI) +4
Start: 2020-08-21End: 2023-02-06Updated: 2026-02-27
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
CompletedNCT06086626
ShionogiGram-Negative Bacterial Infections
Start: 2024-03-14End: 2025-03-31Updated: 2026-03-02
A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients from Birth to less than 3 Months of Age with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections
Active, not recruitingTCTR20240718005
Shionogi Inc.Aerobic Gram-negative Bacterial Infections Complicated urinary tract infection (cUTI) Complicated intra-abdominal infection (cIAI) Hospital-acquired bacterial pneumonia (HABP) Ventilator-associated (VABP) Bloodstream infection (BSI)/sepsis
Start: 2024-11-01Target: 30Updated: 2026-03-30

Phase 3

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
CompletedNCT02714595
ShionogiBloodstream Infections (BSI), Complicated Urinary Tract Infection (cUTI), Healthcare-associated Pneumonia (HCAP) +3
Start: 2016-09-07End: 2019-04-22Updated: 2021-01-12
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
CompletedNCT03032380
ShionogiHealthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
Start: 2017-10-24End: 2019-04-01Updated: 2020-11-13

Phase 4

Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
CompletedNCT05314764
Hartford HospitalCystic Fibrosis, Pneumonia, Bacterial
Start: 2022-06-01End: 2024-12-11Updated: 2024-12-16
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
RecruitingNCT05922124
Rambam Health Care CampusAcinetobacter Bacteremia, Acinetobacter Pneumonia, Carbapenem Resistant Bacterial Infection
Start: 2024-09-01End: 2026-09-30Target: 734Updated: 2025-08-01
Optimising TREATment for Severe Gram-Negative Bacterial Infections
RecruitingNCT07004049
National University of SingaporeBloodstream Infection, Carbapenem Resistant Bacterial Infection, Hospital Acquired Bacterial Pneumonia +2
Start: 2025-04-21End: 2028-12-31Target: 600Updated: 2025-06-04
Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.
Not yet recruitingCTIS2024-516232-10-00
Centre Hospitalier Universitaire De NimesSerious infections in critically ill patients treated with antibiotics
Target: 200Updated: 2025-10-17
Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
RecruitingNCT07465432
University of TennesseeDrug Clearance After Severe Burn Injury
Start: 2026-02-16End: 2027-02-28Target: 12Updated: 2026-03-12

Unknown Phase

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
NCT03780140
ShionogiBacterial Infections
Updated: 2020-02-28
Use of Cefiderocol in the Management of Gram-Negative Infections
CompletedNCT05789199
ShionogiGram-Negative Infection
Start: 2022-07-31End: 2023-06-16Updated: 2023-06-26

Related Papers

Cefiderocol versus standard therapy for hospital-acquired and health-care-associated Gram-negative bacterial bloodstream infection (the GAME CHANGER trial): an open-label, parallel-group, randomised trial.
2025-10-061 citations
Effectiveness and safety of cefiderocol treatment in patients with Gram-negative bacterial infections in Spain in the early access programme: results of the PERSEUS study
European Journal of Clinical Microbiology & Infectious Diseases2025-03-2513 citations
Cefiderocol treatment for patients infected by Stenotrophomonas maltophilia, Burkholderia cepacia complex and Achromobacter spp.: subgroup analysis from the PERSEUS study
European Journal of Clinical Microbiology & Infectious Diseases2025-03-246 citations
Outcomes with Cefiderocol Treatment in Patients with Bacteraemia Enrolled into Prospective Phase 2 and Phase 3 Randomised Clinical Studies.
2022-02-2013 citations
Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials
Microbial Drug Resistance2022-01-2566 citations
Iron serum levels and iron homeostasis parameters in patients with nosocomial pneumonia treated with cefiderocol: post hoc analysis of the APEKS-NP study.
2022-01-135 citations
Investigator-Driven Randomised Controlled Trial of Cefiderocol versus Standard Therapy for Healthcare-Associated and Hospital-Acquired Gram-negative Bloodstream Infection: Study protocol (the GAME CHANGER trial): study protocol for an open-label, randomised controlled trial
Trials2021-12-0112 citations
Structured patient interview to assess clinical outcomes in complicated urinary tract infections in the APEKS-cUTI study: pilot investigation
Therapeutic Advances in Infectious Disease2021-01-014 citations
US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja®)
Clinical Infectious Diseases2020-12-0147 citations
Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial.
2020-10-12579 citations
Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial.
2020-10-12332 citations
1266. Characterization of Shifts in Minimum Inhibitory Concentrations During Treatment with Cefiderocol or Comparators in the Phase 3 CREDIBLE-CR and APEKS-NP Studies
Open Forum Infectious Diseases2020-10-0112 citations
1302. Cefiderocol Population Pharmacokinetics and Probability of Target Attainment in Plasma and Epithelial Lining Fluid in Patients with Pneumonia, Bloodstream Infection/Sepsis, or Complicated Urinary Tract Infections
Open Forum Infectious Diseases2020-10-015 citations
1311. Intrapulmonary Pharmacokinetics of Cefiderocol in Hospitalized and Ventilated Patients Receiving Standard of Care Antibiotics for Bacterial Pneumonia
Open Forum Infectious Diseases2020-10-015 citations
1316. Pharmacokinetic/Pharmacodynamic Analyses of Cefiderocol in Critically Ill Patients
Open Forum Infectious Diseases2020-10-015 citations
165. Cefiderocol Treatment for Serious Infections Caused by Carbapenem-resistant Bacteria: Post-hoc Analysis of Outcomes by Pathogen in the CREDIBLE-CR Study
Open Forum Infectious Diseases2020-10-013 citations
1271. Efficacy and Safety of Cefiderocol and Best Available Therapy in Patients with Serious Infections Caused by Carbapenem-Resistant Gram-Negative Infections: Results of the Pathogen-Focused Phase 3 CREDIBLE-CR Study
Open Forum Infectious Diseases2020-10-012 citations
1285. Outcomes in Patients with Gram-Negative Bacteremia from Phase 2 and Phase 3 Clinical Trials of Cefiderocol, a Novel Siderophore Cephalosporin
Open Forum Infectious Diseases2020-10-01
Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study.
2019-11-2125 citations
LB4. Efficacy and Safety of Cefiderocol vs. High-Dose Meropenem in Patients with Nosocomial Pneumonia—Results of a Phase 3, Randomized, Multicenter, Double-Blind, Non-Inferiority Study
Open Forum Infectious Diseases2019-10-0117 citations

3 more papers not shown