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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies how a combination of an antibiotic and a helper drug works in obese ICU patients who are not currently infected.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic parameters of imipenem and relebactam
Secondary study objectives
Safety of imipenem and relebactam

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for critical illness, such as the combination of Imipenem and Relebactam, work by targeting bacterial infections through dual mechanisms. Imipenem inhibits bacterial cell wall synthesis, leading to cell death, while Relebactam inhibits beta-lactamase enzymes that would otherwise degrade Imipenem. This combination enhances the antibiotic's efficacy against resistant bacteria. For critically ill patients, this approach is vital as it addresses severe infections more effectively, reducing mortality and improving outcomes by overcoming bacterial resistance.
The systemic inflammatory response syndrome (SIRS): immunology and potential immunotherapy.Effects of imipenem combined with low-dose cyclophosphamide on the intestinal barrier in septic rats.β-Blockers in sepsis: protocol for a systematic review and meta-analysis of randomised control trials.

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
639 Previous Clinical Trials
1,568,786 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,803 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
~0 spots leftby Dec 2025