NCT04282785

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-30
• Completion: 2023-08-10
• First posted: 2020-02-25
• Last updated: 2025-06-11

Locations

1 site across 1 country: Sweden