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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linezolid | patients treated with linezolid |
| |
| meropenem | patients treated with meropenem |
| |
| piperacillin/tazobactam | patients treated with piperacillin/tazobactam |
| |
| vancomycin | patients treated with vancomycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to Intensive Care Unit (ICU)
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Finazzi, PhD | Mario Negri Institute for Pharmacological Research | Principal Investigator |
| Elena Garbero, M.Sci | Mario Negri Institute for Pharmacological Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva | Cesena | Emilia-Romagna | 47023 | Italy | ||
| Ospedale S. Giovanni di Dio ASL 10, Servizio Anestesia e Rianimazione |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007239 | Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D000077731 | Meropenem |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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Blood samples to measure antibiotic plasma concentration
| Meropenem | Drug | 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. |
|
| Piperacillin-tazobactam combination product | Drug | 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. |
|
| Vancomycin | Drug | 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. |
|
| Florence |
| FI |
| 50143 |
| Italy |
| Ospedale San Giovanni di Dio | Orbetello | Grosseto | 58016 | Italy |
| Presidio Ospedaliero "San Leopoldo Mandic" | Merate | Lecco | 23807 | Italy |
| Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1 | Lecco | Lombardy | 23900 | Italy |
| Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA | Turin | Piedmont | 10148 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | PV | 27100 | Italy |
| Ospedale del Mugello | Borgo San Lorenzo | Tuscany | 50032 | Italy |
| Ospedale Santa Maria Nuova, Anestesia e Rianimazione | Florence | Tuscany | 50122 | Italy |
| Ospedale Maggiore, C.A. Pizzardi | Bologna | 40133 | Italy |
| Ospedale Misericordia | Grosseto | 58016 | Italy |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |