Cefiderocol PK in Patients on ECMO
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.
Conditions:
🦠 Sepsis
🗓️ Study Start (Actual) 16 July 2021
🗓️ Primary Completion (Estimated) 16 July 2024
✅ Study Completion (Estimated) 16 July 2024
👥 Enrollment (Estimated) 8
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Hartford, Connecticut, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18 years of age or older
    • * On support with veno-venous- or veno-arterial-ECMO

    Exclusion Criteria:

    • * Females who are pregnant or breast-feeding
    • * History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
    • * Receiving Cefiderocol to treat documented or suspected infection within 72 hours of screening, or expected to receive Cefiderocol during the study intervention phase
    • * Severe renal dysfunction defined as a CrCL \< 15 mL/min (as calculated by the Cockcroft Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
    • * A hemoglobin less than 7.2 gm/dl at baseline
    • * Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal, or AST or ALT \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal
    • * Any rapidly progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
    • * Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 July 2021
  • First Submitted that Met QC Criteria 30 July 2021
  • First Posted 9 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 February 2024
  • Last Update Posted 9 February 2024
  • Last Verified February 2024