AbioKin - Antibiotic Kinetics

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project. For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.

Official Title
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Antibiotic Pharmacokinetics in Critically Ill Patients

Conditions
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Critical Illness, Infection

Intervention / Treatment
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* Drug: Linezolid
* Drug: Meropenem
* Drug: Piperacillin-tazobactam combination product
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing antibiotic therapy with amikacin, linezolid, meropenem, piperacillin/tazobactam, or vancomycin. patients whose antibiotic therapy started during the stay in ICU or less than 24h before admission to ICU. patients with anticipated length of stay in ICU of at least 24h. patients with already-placed catheter Exclusion Criteria: patients undergoing antibiotic prophylaxis lack of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| linezolid<br>patients treated with linezolid | Drug: Linezolid<br>* Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.<br>|
| meropenem<br>patients treated with meropenem | Drug: Meropenem<br>* Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.<br>|
| piperacillin/tazobactam<br>patients treated with piperacillin/tazobactam | Drug: Piperacillin-tazobactam combination product<br>* Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.<br>|
| vancomycin<br>patients treated with vancomycin | Drug: Vancomycin<br>* Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug plasma concentration (time-dependent antibiotics) |  | 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment | 
| Drug plasma concentration (concentration-dependent antibiotics) |  | 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Infective Agents, Pharmacokinetics, Critically ill patients