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Not yet recruiting NCT07666230

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

Observational Bacterial Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bacterial Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Blood levels of beta-lactam antibiotics [Time frame: Daily, approximately 5-10 days from start of anibiotic therapy (and enrollment) to the end of antibiotic therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07666230 · 13/7/23 - A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗