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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken part in another clinical trial and received a drug or new medication within 30 days before starting this trial.You are currently breastfeeding.You are currently taking valproic acid or divalproex sodium.The doctor decides that you may not be a good fit for this study due to other health conditions.You have a history of seizures and/or are taking medication to treat seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacokinetic cohort
- Group 2: Safety cohort
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.