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

NCT04282785 | Completed

• 1 other identifier: ABABS001
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Infection, Bacterial

Keywords

meropenem; cefotaxime; piperacillin/tazobactam; Drug Monitoring; Antibiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agreement in antibiotic concentration change in blood after antibiotic administration with UV-VIS technique vs HPLC-MS

  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.

Study Arms (1)

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

Interventions

Concentration monitoring of antibiotics in plasma DIAGNOSTIC_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.

Cohort of patients with severe infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Intermittent haemodialysis
• Patient with limited treatment decision

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala university hospital

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (20)

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MeSH Terms

Conditions

Sepsis; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Miklos Lipcsey

  Department of surgical science, Uppsala University hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: February 25, 2020
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: August 10, 2023
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

SE (1)