14 completed, 3 recruiting, 2 not yet recruiting, 1 approved for marketing. 6 Phase 1, 6 Phase 2, 4 Phase 4, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Phase 2 | 6 | Completed 5, Not yet recruiting 1 |
| Phase 4 | 4 | Recruiting 3, Completed 1 |
| Phase 3 | 3 | Completed 2, Not yet recruiting 1 |
Follow Cefiderocol: new trials by email Literature Review of Cefiderocol trials Research Report on Cefiderocol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation Ceftazidime - Avibactam ( CAZ-AVI), Meropenem-Vaborbactam, Imipenem+Relebactam - Liver Transplant, Carbapenem-resistant Enterobacterales | Phase 3 | Not yet recruiting | IRCCS Azienda Ospedaliero-Universitaria di Bologna | 168 | 2026-10-01 | 2026-08-12 |
| Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT) - Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP) | Phase 2 | Not yet recruiting | BioVersys AG | 120 | 2026-07-01 | 2026-02-24 |
| Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries Cefiderocol - Drug Clearance After Severe Burn Injury | Phase 4 | Recruiting | University of Tennessee | 12 | 2026-02-16 | 2026-03-12 |
| A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment Cefiderocol/Xeruborbactam - Bacterial Infections | Phase 1 | Completed | Qpex Biopharma, Inc. | 40 | 2025-09-16 | 2026-09-25 |
| Optimising TREATment for Severe Gram-Negative Bacterial Infections Colistin/Polymyxin B + Sulbactam, Colistin/Polymyxin B + Tigecycline/Eravacycline, Colistin/Polymyxin B + Meropenem - Bloodstream Infection, Ventilator Associated Bacterial Pneumonia | Phase 4 | Recruiting | National University of Singapore | 600 | 2025-04-21 | 2025-06-04 |
| A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants Xeruborbactam, Cefiderocol, Xeruborbactam/Cefiderocol - Bacterial Infections | Phase 1 | Completed | Qpex Biopharma, Inc. | 60 | 2024-09-04 | 2025-11-28 |
| Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii Cefiderocol, Ampicillin-sulbactam, Colistin - Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia | Phase 4 | Recruiting | Rambam Health Care Campus | 734 | 2024-09-01 | 2025-08-01 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants Cefiderocol, Standard of Care - Gram-Negative Bacterial Infections | Phase 2 | Completed | Shionogi | 30 | 2024-03-14 | 2026-03-02 |
| Use of Cefiderocol in the Management of Gram-Negative Infections Cefiderocol - Gram-Negative Infection | Completed | Shionogi | 314 | 2022-07-31 | 2023-06-26 | |
| Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy Cefiderocol - Pharmacokinetics | Phase 1 | Completed | Hartford Hospital | 14 | 2022-07-25 | 2024-12-18 |
| Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis Cefiderocol - Cystic Fibrosis, Pneumonia, Bacterial | Phase 4 | Completed | Hartford Hospital | 10 | 2022-06-01 | 2024-12-16 |
| A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants Midazolam, Cefiderocol - Healthy Volunteers | Phase 1 | Completed | Shionogi | 14 | 2022-05-24 | 2023-12-14 |
| Cefiderocol PK in Patients on ECMO Cefiderocol - Sepsis | Phase 1 | Completed | Joseph L. Kuti, PharmD | 5 | 2021-07-16 | 2024-12-16 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants Cefiderocol, Standard of Care - Gram-negative Bacterial Infections, Bloodstream Infections (BSI) | Phase 2 | Completed | Shionogi | 53 | 2020-08-21 | 2026-02-27 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants Cefiderocol, Standard of Care - Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP) | Phase 2 | Completed | Shionogi | 91 | 2020-02-19 | 2025-05-25 |
| RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI Cefiderocol, Best Available Therapy - Bloodstream Infections | Phase 2 | Completed | The University of Queensland | 513 | 2019-10-28 | 2024-02-13 |
| Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia Cefiderocol, Standard of Care Antibiotic - Bacterial Pneumonia | Phase 1 | Terminated | Shionogi | 7 | 2019-02-20 | 2020-11-05 |
| Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens Cefiderocol, Meropenem, Linezolid - Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP) | Phase 3 | Completed | Shionogi | 300 | 2017-10-24 | 2020-11-13 |
| Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Cefiderocol, Best Available Therapy - Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI) | Phase 3 | Completed | Shionogi | 152 | 2016-09-07 | 2021-01-12 |
| A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections Cefiderocol, Imipenem/cilastatin - Urinary Tract Infections | Phase 2 | Completed | Shionogi | 452 | 2015-02-05 | 2019-12-12 |
Showing 20 of 21. Sign in to see all of them.
Sepsis (6) · Gram-Negative Bacterial Infections (4) · Bacterial Infections (3) · Healthcare-Associated Pneumonia (3) · Pneumonia, Ventilator-Associated (3) · Pneumonia, Bacterial (2) · Burns (1) · Central Nervous System Infections (1) · Cerebral Ventriculitis (1) · Cystic Fibrosis (1) · Meningitis, Bacterial (1) · Pneumonia (1) · Urinary Tract Infections (1)
Shionogi (10) · Hartford Hospital (2) · Qpex Biopharma, Inc. (2) · BioVersys AG (1) · IRCCS Azienda Ospedaliero-Universitaria di Bologna (1) · Joseph L. Kuti, PharmD (1) · National University of Singapore (1) · Rambam Health Care Campus (1) · The University of Queensland (1) · University of Tennessee (1)
United States (12) · Spain (6) · Taiwan (4) · Thailand (4) · Australia (3) · Georgia (3) · Israel (3) · Turkey (Türkiye) (3) · Ukraine (3) · Belgium (2) · Estonia (2) · France (2) · Germany (2) · Greece (2) · Hungary (2)
Joseph L Kuti, PharmD (2) · Dafna Yahav (1) · David Paterson, Professor (1) · Maddalena Giannella, MD, PhD (1) · Marco Falcone (1) · Mical Paul (1) · Richard Preston, MD (1) · Thomas Marbury, MD (1)
PMID 34792787, PMID 39230271, PMID 33393598, PMID 35076335, PMID 29456043, PMID 30509675, PMID 31819544, PMID 33058795, PMID 33058798, PMID 34868583, PMID 34876196, PMID 35025025, PMID 40126766, PMID 40131647, PMID 41067237, PMID 41118352
2019 (2), 2015 (1), 2016 (1), 2025 (1)