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Carbapenem

Imipenem-Relebactam for Obesity in ICU Patients

Phase 4

Waitlist Available

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is to study the effects of a certain drug on obese people in ICU.

Who is the study for?

This trial is for obese ICU patients with a BMI of 40 or more, or weighing at least 120 kg. They must be adults (18+), not currently infected but in the ICU, and able to consent to the study. Exclusions include kidney issues (low creatinine clearance), current infection treatments, past study participation, known allergies to similar drugs, high serum creatinine levels, recent involvement in other drug trials, pregnancy or breastfeeding women, use of certain seizure medications.Check my eligibility

What is being tested?

The trial tests how obesity affects the body's handling of Imipenem-Relebactam (a combination antibiotic) given at a dose of 1.25g. It involves multiple doses and monitors non-infected obese ICU patients over time to understand this relationship.See study design

What are the potential side effects?

While specific side effects are not listed here for Imipenem-Relebactam in obese ICU patients, common ones may include allergic reactions like rashes or itching; gastrointestinal symptoms such as nausea and vomiting; potential liver enzyme changes; and risk of seizures especially if there's a history.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetic parameters of imipenem and relebactam

Secondary outcome measures

Safety of imipenem and relebactam

Trial Design

2Treatment groups

Experimental Treatment

Group I: Safety cohortExperimental Treatment1 Intervention

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

Group II: Pharmacokinetic cohortExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

607 Previous Clinical Trials

1,559,344 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,559 Total Patients Enrolled

Media Library

Imipenem/Cilastatin (Carbapenem) Clinical Trial Eligibility Overview. Trial Name: NCT05146154 — Phase 4

Critical Illness Research Study Groups: Pharmacokinetic cohort, Safety cohort

Critical Illness Clinical Trial 2023: Imipenem/Cilastatin Highlights & Side Effects. Trial Name: NCT05146154 — Phase 4

Imipenem/Cilastatin (Carbapenem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05146154 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies in this medical experiment for volunteers?

"Clinicaltrials.gov confirms that this study has ceased enrolling patients, as the trial was initially published on January 1st 2023 and last updated November 1st 2022. However, there are still 1129 other medical trials recruiting volunteers at present."

Answered by AI

How many participants are being selected for this clinical research project?

"This particular investigation is no longer open to new patients; the trial was initially posted on January 1st 2023 and its last update happened in November 2022. Alternatively, you may be interested in investigating 1123 other trials which are currently accepting critically ill participants or 6 studies involving Imipenem/Cilastatin/Relebactam at a dosage of 1.25g."

Answered by AI

Is this endeavor a pioneering undertaking?

"Presently, 6 clinical studies involving Imipenem/Cilastatin/Relebactam 1.25g are in progress across 9 countries and 5 cities. The pioneering investigation of this medication, conducted by Pfizer in 2011 with 60 volunteers, was the first to reach Phase 4 drug regulatory approval. Since then, 35 trials have concluded their research processes."

Answered by AI

What is the primary purpose of administering Imipenem/Cilastatin/Relebactam 1.25g?

"Imipenem/Cilastatin/Relebactam 1.25g is the standard therapy for endocarditis caused by staphylococcus aureus and has been used to treat pyelonephritis, abdominal infection, and urinary tract infections as well."

Answered by AI

To what extent is Imipenem/Cilastatin/Relebactam 1.25g hazardous for patients?

"Imipenem/Cilastatin/Relebactam 1.25g can be assessed as being of a high safety profile due to its Phase 4 trial status, which reflects an already-approved treatment. This is represented by the score of 3 assigned by Power's internal evaluation system."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Eric R Wenzler 2023. "Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05146154.