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

June 18, 2026 updated by: Dr. T. Perl
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. T. Perl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/7/23 - A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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