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

Phase 4

Withdrawn

• Conditions: Obesity; Critical Illness
• Interventions: Drug: Imipenem/Cilastatin/Relebactam 1.25g

• Registration Number: NCT05146154
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-13
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-06
• Study Start: 2023-01-01
• Primary Completion: 2023-06-01
• Study Completion: 2024-01-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic cohort	Imipenem/Cilastatin/Relebactam 1.25g	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.
Safety cohort	Imipenem/Cilastatin/Relebactam 1.25g	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of imipenem and relebactam	6 months	Apparent volume of distribution (Vd)

Secondary Outcome Measures

Name	Time	Method
Safety of imipenem and relebactam	6 months	Monitoring for adverse drug events

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States