Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy
NCT ID: NCT04282785
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2022-08-01
2023-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort of patients with severe infections
Patients with severe infections admitted to the Uppsala University Hospital and gets treated with either Piperacillin-Tazobactam, Meropenem or Cefotaxim
Concentration monitoring of antibiotics in plasma
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.
Interventions
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Concentration monitoring of antibiotics in plasma
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.
Eligibility Criteria
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Inclusion Criteria
* Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed
Exclusion Criteria
* Intermittent haemodialysis
* Patient with limited treatment decision
18 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Miklos Lipcsey
Role: PRINCIPAL_INVESTIGATOR
Department of surgical science, Uppsala University hospital
Locations
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Uppsala university hospital
Uppsala, Uppsala County, Sweden
Countries
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References
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Brink AJ, Richards GA, Schillack V, Kiem S, Schentag J. Pharmacokinetics of once-daily dosing of ertapenem in critically ill patients with severe sepsis. Int J Antimicrob Agents. 2009 May;33(5):432-6. doi: 10.1016/j.ijantimicag.2008.10.005. Epub 2008 Dec 16.
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Green L, Dick JD, Goldberger SP, Angelopulos CM. Prolonged elimination of piperacillin in a patient with renal and liver failure. Drug Intell Clin Pharm. 1985 Jun;19(6):427-9. doi: 10.1177/106002808501900604.
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Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.
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Liu KD, Thompson BT, Ancukiewicz M, Steingrub JS, Douglas IS, Matthay MA, Wright P, Peterson MW, Rock P, Hyzy RC, Anzueto A, Truwit JD; National Institutes of Health National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Acute kidney injury in patients with acute lung injury: impact of fluid accumulation on classification of acute kidney injury and associated outcomes. Crit Care Med. 2011 Dec;39(12):2665-71. doi: 10.1097/CCM.0b013e318228234b.
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Roberts DM, Roberts JA, Roberts MS, Liu X, Nair P, Cole L, Lipman J, Bellomo R; RENAL Replacement Therapy Study Investigators. Variability of antibiotic concentrations in critically ill patients receiving continuous renal replacement therapy: a multicentre pharmacokinetic study. Crit Care Med. 2012 May;40(5):1523-8. doi: 10.1097/CCM.0b013e318241e553.
Roberts JA, Paul SK, Akova M, Bassetti M, De Waele JJ, Dimopoulos G, Kaukonen KM, Koulenti D, Martin C, Montravers P, Rello J, Rhodes A, Starr T, Wallis SC, Lipman J; DALI Study. DALI: defining antibiotic levels in intensive care unit patients: are current beta-lactam antibiotic doses sufficient for critically ill patients? Clin Infect Dis. 2014 Apr;58(8):1072-83. doi: 10.1093/cid/ciu027. Epub 2014 Jan 14.
Salam FA, Shoaib MH, Yousuf RI, Sultan F, Khan MA, Manzoor S. Simultaneous quantitation of Ofloxacin, Fexofenadine HCl and Diclofenac Potassium in affixed dose combinative formulation by HPLC-UV method. Pak J Pharm Sci. 2015 Nov;28(6):1979-84.
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Other Identifiers
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ABABS001
Identifier Type: -
Identifier Source: org_study_id
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