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

University of Illinois

Status and phase: Withdrawn; Phase 4

Conditions: Critical Illness; Obesity

Treatments: Drug: Imipenem/Cilastatin/Relebactam 1.25g

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05146154

2021-1145

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pharmacokinetic cohort

Experimental group

Description:

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.

Treatment:

Drug: Imipenem/Cilastatin/Relebactam 1.25g

Safety cohort

Experimental group

Description:

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

Treatment:

Drug: Imipenem/Cilastatin/Relebactam 1.25g