Imipenem/Cilastatin/Relebactam PK in ECMO

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

Summary

Extracorporeal membrane oxygenation (ECMO) is a from 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 re-infused 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, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph L. Kuti, PharmD
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cilastatin; Imipenem; MK-7655; Relebactam

Criteria

Inclusion Criteria:

• Age 18 years or older;

• On support with Veno-venous- or Veno-arterial-ECMO;

• Documented infection or presumed infection as confirmed by the presence of at least one of the following criteria within the past 72 hours:

• Documented fever (oral, rectal, tympanic, or core temperature > 38.5° C)

• Hypothermia (oral, rectal, tympanic, or core temperature < 35.0° C)

• An elevated white blood cell (WBC) count ≥ 12,000 cells/mm3

Exclusion Criteria:

• If female, currently pregnant or breast feeding;

• History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam agent (a history of mild rash to a β-lactam followed by uneventful re-exposure is not a contraindication);

• Severe renal dysfunction defined as a creatinine clearance < 15 mL/min (calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis;

• Hemoglobin less than 8 mg/dL at baseline;

• Use of probenecid, valproic acid, or imipenem within 3 days before study drug infusion;

• 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;

• Planned or prior participation in any other interventional drug study within 30 days.