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

NCT05146154 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2021-1145
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Critical Illness

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameters of imipenem and relebactam

  Peak Plasma Concentration (Cmax)

  6 months

• Pharmacokinetic parameters of imipenem and relebactam

  Area under the plasma concentration versus time curve (AUC)

  6 months

• Pharmacokinetic parameters of imipenem and relebactam

  Total body clearance (CLt)

  6 months

• Pharmacokinetic parameters of imipenem and relebactam

  Apparent volume of distribution (Vd)

  6 months

Secondary Outcomes (1)

• Safety of imipenem and relebactam

  6 months

Study Arms (2)

Pharmacokinetic cohort

EXPERIMENTAL

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

Safety cohort

EXPERIMENTAL

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

Interventions

Imipenem/Cilastatin/Relebactam 1.25g DRUG

Imipenem/cilastatin/relebactam is a combination beta-lactam/beta-lactamase inhibitor antimicrobial marketed under the brand name Recarbrio and the approved dose is 1.25g Q6h in patients with normal renal function. The individual components of this agent must be administered together and cannot be separated. Therefore, this constitutes only one intervention. Each subject will receive at least 2 doses of study drug.

Also known as: Recarbrio

Pharmacokinetic cohort; Safety cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Obesity; Critical Illness

Interventions

Imipenem; Cilastatin; relebactam; imipenem, cilastatin and relebactam

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: December 6, 2021
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)