A Phase 4 interventional study of Imipenem/Cilastatin/Relebactam 1.25g in Obesity and Critical Illness, sponsored by University of Illinois at Chicago. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by University of Illinois at Chicago · Phase 4, Interventional, and Other
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
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Exclusion Criteria:
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
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.
Also known as: Recarbrio
Pharmacokinetic parameters of imipenem and relebactam
Peak Plasma Concentration (Cmax)
Time frame: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Area under the plasma concentration versus time curve (AUC)
Time frame: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Total body clearance (CLt)
Time frame: 6 months
Pharmacokinetic parameters of imipenem and relebactam
Apparent volume of distribution (Vd)
Time frame: 6 months
Safety of imipenem and relebactam
Monitoring for adverse drug events
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago