SepsisNCT04282785

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

An observational study of Sepsis and Infection, Bacterial, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective clinical study will investigate if antibiotic concentrations in patients with severe infections can be monitored by the UV-VIS spectroscopy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis, Infection, Bacterial
What is being tested?: Concentration monitoring of antibiotics in plasma
How many people: 36 participants
Where: 1 siteSweden
Study dates: 1 Aug 2022to 10 Aug 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All Patients with suspected infection that is prescribed with antibiotics (cefotaxime, piperacillin/tazobactam or meropenem) that is hospitalized and admitted to the infection ward, Intermediate ward or ICU.

Who may be able to join

More than 18 years old
Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed

Who cannot join

Pregnancy
Intermittent haemodialysis
Patient with limited treatment decision

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Uppsala university hospital
Uppsala, Uppsala County, 75185

Other trials in Sweden

About this study

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

Read the detailed description

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.

Conditions: Sepsis, Infection, Bacterial
Being tested: Concentration monitoring of antibiotics in plasma
Keywords: meropenem, cefotaxime, piperacillin/tazobactam, Drug Monitoring, Antibiotics
Medical subject headings: Sepsis, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Concentration monitoring of antibiotics in plasmaDiagnostic test
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.

Study groups in NCT04282785
Study group	Role	What they receive
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 Receives: Diagnostic Test: Concentration monitoring of antibiotics in plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 0-48 hours of antibiotic treatment.

Secondary outcomes (1)

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).
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202210 Aug 2023

First posted25 Feb 2020
Study start1 Aug 2022
Primary completion30 Jun 2023
Study completion10 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Uppsala UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04282785
Sponsor's protocol ID: ABABS001
Status last verified: Jun 2025
First submitted: 18 Apr 2019
Last updated: 11 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.
PubMed 19066848
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.
PubMed 19091521
Fuchs M, Sanyal AJ. Sepsis and cholestasis. Clin Liver Dis. 2008 Feb;12(1):151-72, ix. doi: 10.1016/j.cld.2007.11.002.
PubMed 18242502
Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.
PubMed 21545483
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.
PubMed 4006736
SAFE Study Investigators; Finfer S, McEvoy S, Bellomo R, McArthur C, Myburgh J, Norton R. Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis. Intensive Care Med. 2011 Jan;37(1):86-96. doi: 10.1007/s00134-010-2039-6. Epub 2010 Oct 6.
PubMed 20924555
Jager NG, van Hest RM, Lipman J, Taccone FS, Roberts JA. Therapeutic drug monitoring of anti-infective agents in critically ill patients. Expert Rev Clin Pharmacol. 2016 Jul;9(7):961-79. doi: 10.1586/17512433.2016.1172209. Epub 2016 Apr 15.
PubMed 27018631
Kieft H, Hoepelman AI, Knupp CA, van Dijk A, Branger JM, Struyvenberg A, Verhoef J. Pharmacokinetics of cefepime in patients with the sepsis syndrome. J Antimicrob Chemother. 1993 Nov;32 Suppl B:117-22. doi: 10.1093/jac/32.suppl_b.117.
PubMed 8150754
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.
PubMed 16625125
Lau AH, Kronfol NO, John E. Increased vancomycin elimination with continuous hemofiltration. ASAIO Trans. 1987 Jul-Sep;33(3):772-4. No abstract available.
PubMed 3676016
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.
PubMed 21785346
Macnab MS, Macrae DJ, Guy E, Grant IS, Feely J. Profound reduction in morphine clearance and liver blood flow in shock. Intensive Care Med. 1986;12(5):366-9. doi: 10.1007/BF00292927.
PubMed 3771915
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.
PubMed 22511133
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.
PubMed 24429437
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.
PubMed 26639475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy
ClinicalTrials.gov ID: NCT04282785
Acronym / sponsor ID: ABABS001
Conditions: Sepsis, Infection, Bacterial
Keywords: meropenem, cefotaxime, piperacillin/tazobactam, Drug Monitoring, Antibiotics
Study type: Observational
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Uppsala UniversityUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 10 Aug 2023 (actual)
First posted: 25 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The goal of this project is to investigate if antibiotic concentrations in patients could be monitored by the UV-VIS spectroscopy.

After informed consent, samples will be taken prior to antibiotic treatment and three times thereafter. Demographic and clinical data will be registered.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort of patients with severe infections	–	Diagnostic Test: Concentration monitoring of antibiotics in plasmaPatients with severe infections admitted to the Uppsala University Hospital and gets treated with either Piperacillin-Tazobactam, Meropenem or Cefotaxim

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All Patients with suspected infection that is prescribed with antibiotics (cefotaxime, piperacillin/tazobactam or meropenem) that is hospitalized and admitted to the infection ward, Intermediate ward or ICU.

Key inclusion criteria (2 listed)

More than 18 years old
Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed

Key exclusion criteria (3 listed)

Pregnancy
Intermittent haemodialysis
Patient with limited treatment decision

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Concentration monitoring of antibiotics in plasmaPlasma 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.	Diagnostic test	Cohort of patients with severe infections

Primary outcome

Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot.
Time frame: 0-48 hours of antibiotic treatment.
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).

1 secondary outcome

Agreement in antibiotic concentration change in blood after antibiotic administration with UV-VIS technique vs HPLC-MS
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Background: PubMed 19066848Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.
Background: PubMed 19091521Brink 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.
Background: PubMed 18242502Fuchs M, Sanyal AJ. Sepsis and cholestasis. Clin Liver Dis. 2008 Feb;12(1):151-72, ix. doi: 10.1016/j.cld.2007.11.002.
Background: PubMed 21545483Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.
Background: PubMed 4006736Green 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.
Background: PubMed 20924555SAFE Study Investigators; Finfer S, McEvoy S, Bellomo R, McArthur C, Myburgh J, Norton R. Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis. Intensive Care Med. 2011 Jan;37(1):86-96. doi: 10.1007/s00134-010-2039-6. Epub 2010 Oct 6.
Background: PubMed 27018631Jager NG, van Hest RM, Lipman J, Taccone FS, Roberts JA. Therapeutic drug monitoring of anti-infective agents in critically ill patients. Expert Rev Clin Pharmacol. 2016 Jul;9(7):961-79. doi: 10.1586/17512433.2016.1172209. Epub 2016 Apr 15.
Background: PubMed 8150754Kieft H, Hoepelman AI, Knupp CA, van Dijk A, Branger JM, Struyvenberg A, Verhoef J. Pharmacokinetics of cefepime in patients with the sepsis syndrome. J Antimicrob Chemother. 1993 Nov;32 Suppl B:117-22. doi: 10.1093/jac/32.suppl_b.117.
Background: PubMed 16625125Kumar 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.
Background: PubMed 3676016Lau AH, Kronfol NO, John E. Increased vancomycin elimination with continuous hemofiltration. ASAIO Trans. 1987 Jul-Sep;33(3):772-4. No abstract available.
Background: PubMed 21785346Liu 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.
Background: PubMed 3771915Macnab MS, Macrae DJ, Guy E, Grant IS, Feely J. Profound reduction in morphine clearance and liver blood flow in shock. Intensive Care Med. 1986;12(5):366-9. doi: 10.1007/BF00292927.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miklos Lipcsey principal investigator

Department of surgical science, Uppsala University hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Infection, Bacterial, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot. (time frame: 0-48 hours of antibiotic treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04282785, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.