Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy

Study Overview
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Brief Summary
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This prospective clinical study will investigate if antibiotic concentrations in patients with severe infections can be monitored by the UV-VIS spectroscopy.

Detailed Description
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Early and correct antibiotic treatment has a fundamental effect on survival in severe infections, and to prevent resistance development. However, it is unclear if this is achieved in severely ill patients with severe infections. Underdosing of antibiotics leads to lack of effect against bacteria and selection of multi-resistant strains. Overdosing of antibiotics increases the risk of toxicity and poses a threat to the environment. Currently there is no method for rapid or bedside determination of antibiotic concentration in routine health care. Pharmacolog AB, an Uppsala Med-tech company, has developed a technology and a product DrugLog® based on absorption spectroscopy in ultraviolet - visible (UV-VIS) frequencies that can measure the concentration of antibiotics. The goal of this project is to investigate if antibiotic concentrations in patients could be monitored by the UV-VIS spectroscopy. In a prospective observational study, blood samples from 100 patients with severe infections treated with cefotaxime, piperacillin/tazobactam or meropenem will be measured by UV-VIS spectroscopy as well as with the golden standard, High-performance liquid chromatography-mass spectrometry (HPLC-MS) at Klinisk farmakologi, Huddinge hospital, Stockholm. After informed consent, samples will be taken prior to antibiotic treatment and three times thereafter. Demographic and clinical data will be registered.

Official Title
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Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy

Conditions
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Sepsis, Infection, Bacterial

Intervention / Treatment
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* Diagnostic Test: Concentration monitoring of antibiotics in plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years old Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed Exclusion Criteria: Pregnancy Intermittent haemodialysis Patient with limited treatment decision

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of patients with severe infections<br>Patients with severe infections admitted to the Uppsala University Hospital and gets treated with either Piperacillin-Tazobactam, Meropenem or Cefotaxim | Diagnostic Test: Concentration monitoring of antibiotics in plasma<br>* Plasma antibiotic concentration will be measured using a bedside method with UV-VIS spectroscopy. These measurements will be validated with golden standard that is HPLC-MS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot. | The antibiotic concentration will be calculated from the change in from transmittance measured with UV-VIS spectroscopy technique and compared with change antibiotic concentration measured with HPLC-MS using linear regression and Bland-Altman plots. The endpoint will be presented as bias (limits of agreement). | 0-48 hours of antibiotic treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement in antibiotic concentration change in blood after antibiotic administration with UV-VIS technique vs HPLC-MS | The antibiotic concentration will be calculated from the change in from transmittance measured with UV-VIS spectroscopy technique and compared with change antibiotic concentration measured with HPLC-MS using linear regression and Bland-Altman plots. The endpoint will be presented as bias (limits of agreement). | Blood samples will be taken just before the first dose of antibiotic, two hours after the first dose of antibiotic, just before the second dose and two hours after the second dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meropenem, cefotaxime, piperacillin/tazobactam, Drug Monitoring, Antibiotics