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

U

Uppsala University

Status

Completed

Conditions

Infection, Bacterial
Sepsis

Treatments

Diagnostic Test: Concentration monitoring of antibiotics in plasma

Study type

Observational

Funder types

Other

Identifiers

NCT04282785
ABABS001

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

Cohort of patients with severe infections
Description:
Patients with severe infections admitted to the Uppsala University Hospital and gets treated with either Piperacillin-Tazobactam, Meropenem or Cefotaxim
Treatment:
Diagnostic Test: Concentration monitoring of antibiotics in plasma

Trial contacts and locations

1

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Central trial contact

Miklos Lipcsey; Paul Skorup

Data sourced from clinicaltrials.gov

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