Clinical trial NCT04282785: Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy
Official title: Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Infection, Bacterial
Keywords: meropenem
cefotaxime
piperacillin/tazobactam
Drug Monitoring
Antibiotics
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement in antibiotic concentration in blood with UV-VIS technique vs. HPLC-MS expressed bias (limits of agreements) in a Bland Altman plot.
timeFrame: 0-48 hours of antibiotic treatment.
Secondary outcomes:
measure: Agreement in antibiotic concentration change in blood after antibiotic administration with UV-VIS technique vs HPLC-MS
timeFrame: 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.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university hospital
Study officials:
affiliation: Department of surgical science, Uppsala University hospital
name: Miklos Lipcsey
role: PRINCIPAL_INVESTIGATOR
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