CLINICAL TRIALS PROFILE FOR FETROJA
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All Clinical Trials for FETROJA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04215991 ↗ | Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Patients | Recruiting | Shionogi | Phase 2 | 2020-02-19 | To assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric patients 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP). |
| NCT04335539 ↗ | Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Patients | Recruiting | Shionogi | Phase 2 | 2020-08-21 | The primary objectives of this study are: - To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric patients 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric patients 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections |
| NCT04995835 ↗ | Cefiderocol PK in Patients on ECMO | Recruiting | Shionogi Inc. | Phase 1 | 2021-07-16 | Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO. |
| NCT04995835 ↗ | Cefiderocol PK in Patients on ECMO | Recruiting | Joseph L. Kuti, PharmD | Phase 1 | 2021-07-16 | Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO. |
| NCT05314764 ↗ | Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis | Not yet recruiting | Indiana University Health Methodist Hospital | Phase 4 | 2022-06-01 | There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study. |
| NCT05314764 ↗ | Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis | Not yet recruiting | Keystone Bioanalytical, Inc. | Phase 4 | 2022-06-01 | There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study. |
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