Imipenem-Relebactam for Obesity in ICU Patients

Overseen By Eric Wenzler, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Illinois at Chicago

Must not be taking: Antimicrobials, Valproic acid

Disqualifiers: Seizures, High creatinine, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like anti-epileptic agents or valproic acid. It's best to discuss your current medications with the study team.

What is the purpose of this trial?

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

Eligibility Criteria

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.

Inclusion Criteria

Provide a signed and dated written informed consent prior to study participation

BMI ≥40 kg/m2 and/or total body weight ≥120 kg

Admitted to the ICU

Exclusion Criteria

Actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection

Estimated creatinine clearance (CLCR) <60 mL/minute as determined by Cockcroft-Gault equation:

Has previously participated in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of imipenem-relebactam, with serial blood samples collected to evaluate pharmacokinetics

6 months

Multiple visits (in-person) for dosing and blood sampling

Safety Monitoring

Safety is monitored closely during study drug dosing and through 72 hours after the last dose

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Imipenem/Cilastatin
• Relebactam

Trial Overview 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.

Participant Groups

Group I: Safety cohort Experimental Treatment 1 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 cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University