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Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.
Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.
For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| critically ill patients | Critically ill patients receiving continuous infusion of piperacillin/tazbactam or cefepim and dosage of plasma concentration of the B lactam administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dosage of concentration of piperacillin and cefepim | Other | Dosage of total plasma concentration of piperacillin and cefepim at different timepoints |
|
| Measure | Description | Time Frame |
|---|---|---|
| to determine the percentage of patients who met the PK/PD targets at 24 hours | PK/PD target was defined as follows: Concentration of piperacillin or cefepim between a lower and a upper limit:
Consequently :
| Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours | PK/PD target "exposure" take into account only the the lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria Consequently :
|
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients admitted to the surgical intensive care unit whatever the reason of admission and who received piperacilin or cefepim with a TDM for sepsis or septic shock during their stay.
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel NOVY | Central Hospital, Nancy, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emmanuel NOVY | Vandœuvre-lès-Nancy | Lorraine | 54500 | France | ||
| Central Hospital |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077723 | Cefepime |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Day 1 |
| factors associated with target attainment at day 1 | effect of age on antibiotic concentration | Statistical analysis after 2 years of inclusion |
| factors associated with target attainment at day 1 | effect of renal clearance on antibiotic concentration | Statistical analysis after 2 years of inclusion |
| factors associated with target attainment at day 1 | effect of presence of septic shock on antibiotic concentration | Statistical analysis after 2 years of inclusion |
| factors associated with dose changing | effect of presence of septic shock on number of dose changing after analyse of antibiotic concentration | Statistical analysis after 2 years of inclusion |
| factors associated with dose changing | effect of renal clearance on number of dose changing after analyse of antibiotic concentration | Statistical analysis after 2 years of inclusion |
| Vandœuvre-lès-Nancy |
| 54500 |
| France |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D012769 | Shock |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |