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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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