Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

Study Overview
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Brief Summary
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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.

Official Title
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Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia

Conditions
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Bacteremia

Intervention / Treatment
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* Drug: Continuous infusion of beta-lactam antibiotics .
* Other: Therapeutic drug monitoring of beta-lactam antibiotics.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a positive blood culture. Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem. Hospitalised at Hvidovre University Hospital. Age ≥ 18. Able to understand and give informed consent. Included in the study within 24 hours after the final positive blood culture answer. Exclusion Criteria: Positive blood culture is interpreted as contamination. The patient dies before the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TDM and CI.<br>Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics. | Drug: Continuous infusion of beta-lactam antibiotics .<br>* Beta-lactam antibiotic will be administered as continous infusion.<br>* Other names: Meropenem;Other: Therapeutic drug monitoring of beta-lactam antibiotics.<br>* Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.<br>|
| No Intervention: Control<br>Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, Bacteraemia