Bacterial InfectionsCBS-IMSNCT07666230
Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry
An observational study of Bacterial Infections, run by Dr. T. Perl.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patents that are treated with beta-lactam antibiotics in the ICU or IMC unit of the Department of General Surgery at UMG
Who may be able to join
- 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
Who cannot join
- Patients without a valid informed consent form
About this study
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
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily, approximately 5-10 days from start of anibiotic therapy (and enrollment) to the end of antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. T. Perl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. T. Perl, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666230
- Sponsor's protocol ID
- 13/7/23 - A1
- Acronym
- CBS-IMS
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Antibiotic Therapy - Point-of-Care Determination of Blood Levels of Beta-Lactam Antibiotics Using Coated-Blade-Spray Ion Mobility Spectrometry
- ClinicalTrials.gov ID
- NCT07666230
- Acronym / sponsor ID
- CBS-IMS / 13/7/23 - A1
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. T. PerlUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patents that are treated with beta-lactam antibiotics in the ICU or IMC unit of the Department of General Surgery at UMG
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients without a valid informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Dr. T. Perl.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.