Critical Illness, Obesity
Conditions
Brief summary
This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
Interventions
DRUGImipenem/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.
Sponsors
Merck Sharp & Dohme LLC
University of Illinois at Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of imipenem and relebactam | 6 months | Peak Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of imipenem and relebactam | 6 months | Monitoring for adverse drug events |
Countries
United States
Outcome results
None listed