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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05146154
• Other study ID #: 2021-1145
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: January 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years of age

2. Admitted to the ICU

3. BMI =40 kg/m2 and/or total body weight =120 kg

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

Exclusion Criteria:

1. History of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam)

2. History of seizures and/or receiving 1 or more anti-epileptic agent

3. Serum creatinine =1.5 mg/dL

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

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

6. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication

7. Positive serum pregnancy test (for women of childbearing potential)

8. Currently breast feeding

9. Has previously participated in this study

10. Concomitant use of valproic acid or divalproex sodium

11. Any other condition that may make the patient unsuitable for the study in the judgement of the investigator

Related Conditions & MeSH terms

• Critical Illness
• Obesity

Intervention

Drug:
• Imipenem/Cilastatin/Relebactam 1.25g
Imipenem/cilastatin/relebactam is a combination beta-lactam/beta-lactamase inhibitor antimicrobial marketed under the brand name Recarbrio and the approved dose is 1.25g Q6h in patients with normal renal function. The individual components of this agent must be administered together and cannot be separated. Therefore, this constitutes only one intervention. Each subject will receive at least 2 doses of study drug.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of imipenem and relebactam	Peak Plasma Concentration (Cmax)	6 months
Primary	Pharmacokinetic parameters of imipenem and relebactam	Area under the plasma concentration versus time curve (AUC)	6 months
Primary	Pharmacokinetic parameters of imipenem and relebactam	Total body clearance (CLt)	6 months
Primary	Pharmacokinetic parameters of imipenem and relebactam	Apparent volume of distribution (Vd)	6 months
Secondary	Safety of imipenem and relebactam	Monitoring for adverse drug events	6 months