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Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients | Clinical Trials | Clareo Health

WITHDRAWNPHASE4

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

NCT05146154•University of Illinois at Chicago

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (1)

University of Illinois at Chicago

Chicago, Illinois, United States

Key Dates

Start Date

January 1, 2023

Primary Completion Date

June 1, 2023

Completion Date

January 1, 2024

Last Updated

November 27, 2024

Conditions

ObesityCritical Illness

Interventions

Imipenem/Cilastatin/Relebactam 1.25g

DRUG

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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