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

Primary Purpose

Obesity, Critical Illness

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Imipenem/Cilastatin/Relebactam 1.25g
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pharmacokinetic cohort

Safety cohort

Arm 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.

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

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of imipenem and relebactam
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameters of imipenem and relebactam
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameters of imipenem and relebactam
Total body clearance (CLt)
Pharmacokinetic parameters of imipenem and relebactam
Apparent volume of distribution (Vd)

Secondary Outcome Measures

Safety of imipenem and relebactam
Monitoring for adverse drug events

Full Information

First Posted
November 13, 2021
Last Updated
November 1, 2022
Sponsor
University of Illinois at Chicago
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05146154
Brief Title
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Official Title
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Critical Illness

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacokinetic cohort
Arm Type
Experimental
Arm 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.
Arm Title
Safety cohort
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Imipenem/Cilastatin/Relebactam 1.25g
Other Intervention Name(s)
Recarbrio
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of imipenem and relebactam
Description
Peak Plasma Concentration (Cmax)
Time Frame
6 months
Title
Pharmacokinetic parameters of imipenem and relebactam
Description
Area under the plasma concentration versus time curve (AUC)
Time Frame
6 months
Title
Pharmacokinetic parameters of imipenem and relebactam
Description
Total body clearance (CLt)
Time Frame
6 months
Title
Pharmacokinetic parameters of imipenem and relebactam
Description
Apparent volume of distribution (Vd)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety of imipenem and relebactam
Description
Monitoring for adverse drug events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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