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

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cilastatin; Imipenem; Relebactam

Criteria

Inclusion Criteria:

1. Age ≥18 years of age

2. Admitted to the ICU

3. BMI ≥40 kg/m2 and/or total body weight ≥120 kg

4. Provide a signed and dated written informed consent prior to study participation

Exclusion Criteria:

1. History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)

2. History of seizures and/or receiving 1 or more anti-epileptic agent

3. Serum creatinine ≥1.5 mg/dL

4. Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:

5. Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection

6. 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

7. Positive serum pregnancy test (for women of childbearing potential)

8. Currently breast feeding

9. Has previously participated in this study

10. Concomitant use of valproic acid or divalproex sodium

11. Any other condition that may make the patient unsuitable for the study in the judgement of the investigator