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

NCT07666230 | Not Yet Recruiting

• 1 other identifier: 13/7/23 - A1
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Blood levels of beta-lactam antibiotics

  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.

  Daily, approximately 5-10 days from start of anibiotic therapy (and enrollment) to the end of antibiotic therapy

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

Patents that are treated with beta-lactam antibiotics in the ICU or IMC unit of the Department of General Surgery at UMG

You may qualify if:

• 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

You may not qualify if:

• Patients without a valid informed consent form

Sponsors & Collaborators

• Dr. T. Perl: lead

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. Thorsten Perl

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 24, 2026

Record last verified: 2026-06