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| ID | Type | Description | Link |
|---|---|---|---|
| 2017/384/HP | Registry Identifier | CHU Rouen |
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Population pharmacokinetic modeling mathematically describes the pharmacokinetics of a drug and the variables likely to influence it in a "typical" patient population. We propose to model a Bayesian estimator, taking into account the individual factors that influence exposure to the piperacillin / tazobactam combination in a target population of sepsis, to allow for early assessment of serum Piperacillin / Tazobactam concentration profiles. optimization of dosing regimens. Indeed, pharmacokinetic tools of this type are already regularly successfully applied for other classes of antibiotics or immunosuppressants whose therapeutic index is narrow. They reduce the toxic risk and optimize the effectiveness of these treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Pharmacokinetic Sampling Cohort |
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| Sparse Pharmacokinetic Sampling Cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Pharmacokinetic Sampling Cohort | Drug | For the first 60 patients, blood samples were collected in 2-mL dry tubes at T0, 90 min, 3 h, 4 h, 5 h, 6 h, 12 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 6 hours; or at T0, 90 min, 3 h, 4 h, 6 h, 8 h, 16 h, 24 h, 48 h, and 120 h if infusions are administered over 3 hours every 8 hours, for piperacillin/tazobactam concentration measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| The objective is to develop a Bayesian estimator of the area under the blood concentration curves of the piperacillin / tazobactam combination in resuscitation patients with sepsis. | The primary endpoint of this study is the ability of the pharmacokinetic model developed to predict the AUC of the piperacillin / tazobactam combination at 24 hours after initiation of antibiotic therapy. | 24hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3"
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rouen | Rouen | France | France |
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| Sparse Pharmacokinetic Sampling Cohort | Drug | For the last 30 patients, blood samples of 2 mL collected in dry tubes at T0, T6h (if administered every 6 hours) or T8h (if administered every 8 hours), then T24h, T48h, and T120h after initiation of treatment via 3-hour infusions. |
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