Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07666230

Acronym

CBS-IMS

Enrollment

200

Registered

2026-06-24

Start date

2026-09-01

Completion date

2029-05-01

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Brief summary

A new analytical method for determining beta-lactam antibiotic concentrations in the blood of intensive care patients is to be evaluated. Patients receive antibiotic therapy with beta-lactam antibiotics in the general surgery intensive care unit. Blood samples are collected daily for routine clinical testing; a portion of these samples is used for the new method. The antibiotic levels, routinely measured using the gold standard, are documented and used as a reference point. The goal of the study is to establish a rapid and cost-effective method for determining beta-lactam antibiotic levels, which will subsequently enable rapid dose adjustment.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Valid informed consent form (prospective, retrospective, or provided by a legal representative) * Antibiotic therapy with a beta-lactam antibiotic in the intensive care unit or intermediate care unit of the Department of General Surgery at UMG

Exclusion criteria

* Patients without a valid informed consent form

Design outcomes

Primary

Measure	Time frame	Description
Blood levels of beta-lactam antibiotics	Daily, approximately 5-10 days from start of anibiotic therapy (and enrollment) to the end of antibiotic therapy	Blood levels of beta-lactam antibiotics are measured both through routine clinical testing and using the newly developed analytical method. Blood samples are collected once a day for this purpose. Changes in blood levels are monitored over several days.

Outcome results