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

NCT05146154 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-11-27

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146154 on ClinicalTrials.gov