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| Name | Class |
|---|---|
| University of the Sciences in Philadelphia | OTHER |
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The study is aiming to describe the pharmacokinetic and pharmacodynamic profile of intravenous meropenem, ertapenem, cefepime, colistin, Ceftazidime/Avibactam , Ceftolozane/Tazobactam , and piperacillin/tazobactam in the plasma and determine how much is removed by Renal Replacement Therapies to ensure adequate dosing
This pharmacokinetic evaluation and clinical outcomes will be an open-label study of 12-16 adult patients/antibiotic dose/modality to a total number of 180-240 patients, admitted to the acute care levels or intensive care unit at Cleveland Clinic Abu Dhabi receiving RRT and prescribed these seven antibiotics as recommended by their treating physicians. The collection of blood, ultrafiltrate or effluent fluids depending on RRT modality (HD or CRRT), and urine samples will begin after participants are administered first dose to determine if a loading dose will be required then after at least three doses (as prescribed by the treating physician) once these drugs will be at steady-state concentration. The study intervention duration will depend on dialysis modality expected to be 3 to 5 days depending on RRT modality and patients will be followed for outcomes (death or cure). Collected blood, effluent and urine samples will be assayed for drug concentration. The concentration data will be modeled by a computer program to determine the pharmacokinetic parameters used to predict future dosing in the case of RRT. Linear/logistic regression will be used as a component of statistical analysis to model the relationship between CRRT machine settings and the amount of the study drugs that will be removed by the filter. Information related to adverse events , clinical and microbiological cure will be collected in case report forms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Other | Pharmacokinetics |
| Measure | Description | Time Frame |
|---|---|---|
| Serum antibiotic concentrations over time during dose interval | Blood will be collected at designated time points, serum samples will be assayed for drug concentration over time to describe pharmacokinetic disposition | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of antibiotic removed by dialysis | Dialysate will be collected and assayed for drug concentration to determine the amount of drug cleared by RRT with respect to different dialysis modalities and membranes | 24 months |
| Time above minimum inhibitory concentration (T/MIC) for time dependent antibiotics |
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Inclusion Criteria:
Exclusion Criteria:
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Patients on renal replacement therapy, prescribed antibiotics in the regular course of care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wasim El Nekidy, PharmD | Contact | +971 2 6590200 | 47969 | ElnekiW@ClevelandClinicAbuDhabi.ae |
| Islam Ghazi, PharmD | Contact | +12152688908 | i.ghazi@usciences.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wasim El Nekidy, PharmD | Cleveland Clinic Abu Dhabi | Principal Investigator |
| Islam Ghazi, PharmD | University of the Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Abu Dhabi | Recruiting | Abu Dhabi | United Arab Emirates |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum
Concentration/time data will be modeled mathematically (population pharmacokinetics and Monte Carlo simulation) to identify adequate dosing in this patient population |
| 24 months |
| Area under concentration time curve over minimum inhibitory concentration for (Cmax/MIC) for concentration dependent antibiotics | Concentration/time data will be modeled mathematically (population pharmacokinetics and Monte Carlo simulation) to identify adequate dosing in this patient population | 24 months |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |