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Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin-clavulanate | Other | Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling |
|
| Piperacillin-tazobactam | Other | Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling |
|
| Meropenem | Other | Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling |
|
| Cefazolin | Other | Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling |
|
| Vancomycin | Other | Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling |
|
| Teicoplanin | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-clavulanate | Other | blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics | The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a percentage of time during which the unbound concentration remains above the Minimal Inhibitory Concentration (MIC) of the micro-organism of at least 50% and a maximum concentration of 10 x MIC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter De Cock, PharmD | Contact | +32 9 332 29 69 | pieter.decock@uzgent.be |
| Name | Affiliation | Role |
|---|---|---|
| Annick de Jaeger, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Fabiola Children's University Hospital | Recruiting | Brussels | Brussels Capital | 1020 | Belgium |
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Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling
|
| Ciprofloxacin | Other | Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling |
|
| Amikacin | Other | Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling |
|
| Piperacillin-tazobactam | Other | blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care. |
|
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| Meropenem | Other | blood sampling in patients receiving meropenem as part of routine clinical care. |
|
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| Cefazolin | Other | blood sampling in patients receiving cefazolin as part of routine clinical care. |
|
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| Vancomycin | Other | blood sampling in patients receiving vancomycin as part of routine clinical care. |
|
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| Teicoplanin | Other | blood sampling in patients receiving teicoplanin as part of routine clinical care. |
|
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| Ciprofloxacin | Other | blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care. |
|
|
| Amikacin | Other | blood sampling in patients receiving amikacin as part of routine clinical care. |
|
|
| up to 1 month |
| Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) | % of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) | % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Teicoplanin: probability of target attainment with the target being a mimimal trough concentration | % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC) | % of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC) | % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration | % of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration | % of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions | up to 1 month |
| Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC) | % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions | July 2026 |
| Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC) | % of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions | July 2026 |
| up to 1 month |
| Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin | The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of ciprofloxacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 86 | up to 1 month |
| Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin | The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of vancomycin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 200 to 300 | up to 1 month |
| Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin | The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of teicoplanin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is an Area-under the concentration-Time Curve of 900 | up to 1 month |
| Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin | The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of amikacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a peak over Minimal Inhibitory Concentration Ratio of 8 to 10, trough concentration below 5 mg/L and Area under the Concentration Time Curve/MIC>399 | up to 1 month |
| Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) | % of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in first dose conditions | up to 1 month |
| Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC) | % of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions | up to 1 month |
| Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC) | % of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions | up to 1 month |
| Teicoplanin: probability of target attainment with the target being a mimimal trough concentration | % of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions | up to 1 month |
| Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC) | % of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions | up to 1 month |
| Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration | % of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions | up to 1 month |
| University Hospital | Recruiting | Ghent | 9000 | Belgium |
|
| Universitair hospital | Recruiting | Leuven | 3000 | Belgium |
|
| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D001800 | Blood Specimen Collection |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D000077731 | Meropenem |
| D002437 | Cefazolin |
| D014640 | Vancomycin |
| D017334 | Teicoplanin |
| D002939 | Ciprofloxacin |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010878 | Piperacillin |
| D013450 | Sulfones |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077427 | Lipoglycopeptides |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
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