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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05146154
Collaborator
Merck Sharp & Dohme LLC (Industry)
12
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Imipenem/Cilastatin/Relebactam 1.25g
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacokinetic cohort

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
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.
Other Names:
  • Recarbrio

    		•
    Experimental: Safety cohort

    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
    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.
    Other Names:
  • Recarbrio

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic parameters of imipenem and relebactam [6 months]

      Peak Plasma Concentration (Cmax)

    2. Pharmacokinetic parameters of imipenem and relebactam [6 months]

      Area under the plasma concentration versus time curve (AUC)

    3. Pharmacokinetic parameters of imipenem and relebactam [6 months]

      Total body clearance (CLt)

    4. Pharmacokinetic parameters of imipenem and relebactam [6 months]

      Apparent volume of distribution (Vd)

    Secondary Outcome Measures

    1. Safety of imipenem and relebactam [6 months]

      Monitoring for adverse drug events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Illinois at Chicago Chicago Illinois United States 60612

    Sponsors and Collaborators

    • University of Illinois at Chicago
    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eric R Wenzler, Assistant Professor, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT05146154
    Other Study ID Numbers:
    • 2021-1145
    First Posted:
    Dec 6, 2021
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Obesity
    Critical Illness
    Imipenem
    Relebactam
    Cilastatin

    Study Results

    No Results Posted as of May 19, 2022