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Investigator is no longer at University of Illinois
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese ICU patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacokinetic cohort | Experimental | 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. |
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| Safety cohort | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imipenem/Cilastatin/Relebactam 1.25g | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of imipenem and relebactam | Peak Plasma Concentration (Cmax) | 6 months |
| Pharmacokinetic parameters of imipenem and relebactam | Area under the plasma concentration versus time curve (AUC) | 6 months |
| Pharmacokinetic parameters of imipenem and relebactam | Total body clearance (CLt) | 6 months |
| Pharmacokinetic parameters of imipenem and relebactam | Apparent volume of distribution (Vd) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of imipenem and relebactam | Monitoring for adverse drug events | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015378 | Imipenem |
| D015377 | Cilastatin |
| C568736 | relebactam |
| C000633884 | imipenem, cilastatin and relebactam |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |