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Logistics
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The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDM and CI. | Experimental | Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics. |
|
| Control | No Intervention | Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous infusion of beta-lactam antibiotics . | Drug | Beta-lactam antibiotic will be administered as continous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target concentrations. | Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem. | 30 days after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity. | Diagnoses compared between the two arms. | 30 days after intervention. |
| Number of days until medically discharged. | Number of days until medically discharged compared between the two arms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Thønnings, MD | Hvidovre University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D000667 | Ampicillin |
| D004009 | Dicloxacillin |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D002444 | Cefuroxime |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Therapeutic drug monitoring of beta-lactam antibiotics. | Other | Dosage of beta-lactam antibiotics will be adjusted according to serum concentration. |
|
| 30 days after intervention. |
| Failed antibiotic treatments. | Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms. | 30 days after intervention. |
| Amount of antibiotic used. | Defined daly doses of antibiotic therapy compared between the two arms. | 30 days after intervention. |
| Antibiotic side effects and complications. | The severity of bacteraemia, mechanical ventilation and start-up of dialysis compared between the two arms. Growth of antibiotic-associated pathogenic in patient material compared between the two arms. | 30 days after intervention. |
| Mortality. | 30-day mortality compared between the two arms. | 30 days after intervention. |
| Number of participants with abnormal clinical data and/or abnormal laboratory values. | Clinical data includes height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale score, body temperature, fous of infection, the severity of bacteraemia, dialysis and laboratory values includes hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase, alanine amino transferase and lactate. Both will be compared between the two arms. | 30 days after intervention. |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003023 | Cloxacillin |
| D010068 | Oxacillin |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010878 | Piperacillin |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D013845 | Thienamycins |
| D015780 | Carbapenems |