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

December 21, 2023 updated by: Uppsala University
This prospective clinical study will investigate if antibiotic concentrations in patients with severe infections can be monitored by the UV-VIS spectroscopy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: 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.

What is the study measuring?

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.
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).
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Miklos Lipcsey, Department of surgical science, Uppsala University hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABABS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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