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The pharmacokinetics of antimicrobials is profoundly modified in Intensive care unit (ICU) patients. To adapt the treatment, it is recommended to measure blood levels of antibiotics. Some antibiotics, such as amikacin, are easy to monitor, while for other molecules, such as piperacillin/tazobactam, the drug monitoring is more difficult to obtain. These two molecules have similar physicochemical characteristics (hydrophilicity) and therefore have closed pharmacokinetic properties. OPTIMA is a study aiming at criteria will be used to judge whether the pharmacokinetic (PK) parameters of amikacin are predictive of those of piperacillin and tazobactam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated by amikacin and piperacillin | Experimental | ICU patient with a sepsis treated by amikacin and piperacillin/tazobactam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma dosage of amikacin, piperacillin and tazobactam | Biological | Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentration of amikacin during the first 24 hours after administration | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) | |
| Change in plasma concentration of piperacillin during the first 24 hours after administration | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) | |
| Change in plasma concentration of tazobactam during the first 24 hours after administration | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) | |
| Dose administered of amikacin at baseline | Hour 0 (Baseline) | |
| Dose administered of piperacillin at baseline | Hour 0 (Baseline) | |
| Dose administered of tazobactam at baseline | Hour 0 (Baseline) | |
| Change in plasma volume of distribution of amikacin during the first 24 hours after administration | In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| Change in plasma volume of distribution of piperacillin during the first 24 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud FRIGGERI, MD | Contact | 478865647 | +33 | arnaud.friggeri@chu-lyon.fr |
| Alain LEPAPE, MD | Contact | 478861989 | +33 | alain.lepape@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Anesthésie et Réanimation - Secteur de Soins Critiques, Groupement Hospitalier Sud, HCL | Recruiting | Pierre-Bénite | 69495 | France |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010878 | Piperacillin |
| D000078142 | Tazobactam |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam.
Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered
| First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| Change in plasma volume of distribution of tazobactam during the first 24 hours after administration | In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma volume of distribution is one of the two PK parameters evaluated in this study (with clearance), calculated with drug plasma concentration and dose administered | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| Change in plasma clearance of amikacin during the first 24 hours after administration | In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| Change in plasma clearance of piperacillin during the first 24 hours after administration | In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| Change in plasma clearance of tazobactam during the first 24 hours after administration | In order to evaluate whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam. Plasma clearance is one of the two PK parameters evaluated in this study (with volume of distribution), calculated with drug plasma concentration and dose administered | First 24 hours of the antimicrobial treatment (Hour 1, Hour 5, Hour 7 and Hour 24) |
| D012769 | Shock |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010397 | Penicillanic Acid |
| D013450 | Sulfones |