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NCT05146154 | Enrolling by invitation | Obesity

Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Sponsor:

University of Illinois at Chicago

Information provided by (Responsible Party):

Eric R Wenzler

Brief Summary:

This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.

Condition or disease

Obesity

Critical Illness

Intervention/treatment

Imipenem/Cilastatin/Relebactam 1.25g

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : January 1, 2024
Arm Intervention/treatment

Experimental: Pharmacokinetic cohort

After at least 2 doses of study drug, serial blood samples will be collected from 12 non-infected, obese ICU patients to evaluate the pharmacokinetics of imipenem and relebactam in this population.

Drug: Imipenem/Cilastatin/Relebactam 1.25g

Experimental: Safety cohort

After at least 2 doses of study drug, safety will be monitored closely during study drug dosing and through 72 hours after the last dose is administered in the same 12 non-infected, obese ICU patients from the PK arm

Drug: Imipenem/Cilastatin/Relebactam 1.25g
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Age ≥18 years of age
  • Admitted to the ICU
  • BMI ≥40 kg/m2 and/or total body weight ≥120 kg
  • Provide a signed and dated written informed consent prior to study participation
Exclusion Criteria
  • History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)
  • History of seizures and/or receiving 1 or more anti-epileptic agent
  • Serum creatinine ≥1.5 mg/dL
  • Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:
  • Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication
  • Positive serum pregnancy test (for women of childbearing potential)
  • Currently breast feeding
  • Has previously participated in this study
  • Concomitant use of valproic acid or divalproex sodium
  • Any other condition that may make the patient unsuitable for the study in the judgement of the investigator
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients

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Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60612