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The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Piperacillin-Tazobactam or Meropenem Cohort | Patients hospitalized for sepsis or septic shock that are treated with Piperacillin-Tazobactam or Meropenem and meet all the inclusion criteria and none of the exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piperacillin/tazobactam or Meropenem | Drug | The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected:
A second complete determination will be made (before the infusion, in the midpoint of time and before the next dose) after the administration of 4 doses as long as a posology modification is made as a consequence of the information received from the plasmatic levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy . | The chosen efficiency parameter is that 100 % of the time the concentration remains 4 times above the minimum inhibitory concentration (MIC), the exact minimum inhibitory concentration (MIC) of the used antibiotic will be determined by E-test by the Microbiology Service which means that the seric concentrations asociated with the maximum therapeutic efficacy are:
| Up to 12 months after the antibiotic administration |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with renal hyper clearance. | The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has renal hyper clearance when they have a creatinine clearance above 130 ml/min. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with sepsis or septic shock who are being treated with Meropenem or Piperacillin-Tazobactam and meet the following criteria and none of the exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta María Pinilla de Torre | Contact | 645. 36. 83. 05 | marta_pinilla@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| José Garnacho Montero | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Seville | 41013 | Spain |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010878 | Piperacillin |
| D000078142 | Tazobactam |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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|
| Up to 12 months after the antibiotic administration |
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with Gram-negative bacillary bacteremia. | The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has Gram-negative bacillary bacteremia when the bloodstream is invaded by Gram-negative bacillary which is diagnosed by blood culture. | Up to 12 months after the antibiotic administration |
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with continuous renal replacement technique. | The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with continuous renal replacement technique, has its blood purified extracorporeally, replacing the renal function continuously 24 hours of the day. | Up to 12 months after the antibiotic administration |
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with ExtraCorporeal Membrane Oxygenation. | The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with ExtraCorporeal Membrane Oxygenation has a short-term extracorporeal circulatory and respiratory mechanical assistance system. | Up to 12 months after the antibiotic administration |
| Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with morbid obesity. | The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has morbid obesity when it´s BMI (body mass index) is above 40. | Up to 12 months after the antibiotic administration |
| Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy. | Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy. | Up to 12 months after the antibiotic administration |
| Determine the association between the supra-therapeutic levels and the appearance of toxicity. | Determination of if there´s an association between the antibiotics supra-therapeutic levels and the toxicity appearance. | Up to 12 months after the antibiotic administration |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 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 |
| D013845 | Thienamycins |
| D015780 | Carbapenems |