What side effects are associated with this type of intervention?

Common side effects of beta-lactam antibiotics, such as imipenem, include gastrointestinal issues like nausea, vomiting, and diarrhea, as well as allergic reactions ranging from rash to anaphylaxis. Neurotoxicity, including seizures, can occur, particularly in patients with renal impairment. Beta-lactamase inhibitors like relebactam can also cause gastrointestinal disturbances and allergic reactions. Combining these agents can increase the risk of nephrotoxicity, especially when used with other nephrotoxic drugs.

What prior FDA approvals exist?

The FDA has approved several beta-lactam/beta-lactamase inhibitor combinations for the treatment of critical illnesses involving severe bacterial infections. These include drugs like Piperacillin-Tazobactam, which combines a penicillin derivative with a beta-lactamase inhibitor, and Ceftazidime-Avibactam, which pairs a third-generation cephalosporin with a novel beta-lactamase inhibitor. These treatments are crucial in managing infections caused by multi-drug resistant organisms, particularly in critically ill patients. Imipenem-Relebactam, currently under study, follows this approach by combining a carbapenem with a beta-lactamase inhibitor to enhance efficacy against resistant pathogens.

What other types of research exist?

Promising novel alternatives to Imipenem-Relebactam for critically ill patients include Ceftazidime-Avibactam and Ceftolozane-Tazobactam. Both combinations have shown efficacy against a broad spectrum of Gram-negative bacteria, including those producing beta-lactamase enzymes. Additionally, these alternatives have been supported by recent clinical studies and reviews for their potential use in severe infections.

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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

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.

Do I qualify?Apply below to find out

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.