Infection, BacterialTAPSINCT03985605
Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI
An observational study of Infection, Bacterial, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Critically ill intensive care patients who were included in the routines TDM-program since January 2018.
Who may be able to join
- routines TDM of antiinfectives
Who cannot join
- TDM is not available
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology of the University Hospital of Munich
Munich, 81377
About this study
Official title: Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness
Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.
Read the detailed description
Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.
- Conditions
- Infection, Bacterial
- Keywords
- TDM, Routine, intensive care patients
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subtherapeutic antiinfective concentrations
Number of subtherapeutic concentrations from different antiinfectives in critically ill patients
Measured: four years
Correlation of meropenem concentration in serum to the concentration in brain fluid
The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration
Measured: during the treatment with an external ventricular drainage
Subtherapeutic antiinfective concentrations during hemoadsorption
Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment
Measured: during hemoadsorption treatment
Secondary outcomes (5)
28-day mortality of patients with therapeutic drug monitoring of antiinfectives
Correlation of antiinfective concentrations in serum to 28-day mortality
Measured: during intensive care treatment
ICU-free days of patients with therapeutic drug monitoring of antiinfectives
Correlation of antiinfective concentrations in serum to ICU-free days to day 28
Measured: during intensive care treatment
Sofa-score course of patients with therapeutic drug monitoring of antiinfectives
Correlation of antiinfective concentrations in serum to sofa-score
Measured: during the treatment with the antiinfectives
Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives
Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients
Measured: during the treatment with the antiinfectives
Time course of CRP in patients with therapeutic drug monitoring of antiinfectives
Correlation of antiinfective concentrations to CRP in critically ill patients
Measured: during the treatment with the antiinfectives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Zoller MD, Ludwig-Maximilians - University of Munich
- Investigators
- Bruegel Mathias, Dr. med., Principal investigator, Institute of Laboratory Medicine of the University Hospital of MunichLiebchen Uwe, Dr.med., Study chair, Department of Anaesthesiology of the University Hospital of MunichInes Schroeder, Dr.med., Study chair, Department of Anaesthesiology of the University Hospital of MunichPaal Michael, Dr.rer.nat., Study chair, Institute of Laboratory Medicine of the University Hospital of MunichBernhard Zwissler, Prof.Dr.med., Study director, Department of Anaesthesiology of the University Hospital of MunichDaniel Teupser, Prof.Dr.med., Study director, Institute of Laboratory Medicine of the University Hospital of MunichLesca Holdt, Prof.Dr.med., Study chair, Institute of Laboratory Medicine of the University Hospital of MunichMichael Vogeser, Prof.Dr.med., Study chair, Institute of Laboratory Medicine of the University Hospital of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985605
- Sponsor's protocol ID
- LMU 18-578
- Acronym
- TAPSI
- Status last verified
- May 2022
- First submitted
- 27 May 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)
Publications
Weber F, Scharf C, Aulin LBS, Weinelt F, Paal M, Mikus G, Vogeser M, Habler K, Huisinga W, Zoller M, Michelet R, Kloft C, Liebchen U. Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study. Infection. 2025 Oct;53(5):1819-1831. doi: 10.1007/s15010-025-02504-0. Epub 2025 Apr 25.
PubMed 40279026Scharf C, Weinelt F, Schroeder I, Paal M, Weigand M, Zoller M, Irlbeck M, Kloft C, Briegel J, Liebchen U. Does the cytokine adsorber CytoSorb(R) reduce vancomycin exposure in critically ill patients with sepsis or septic shock? a prospective observational study. Ann Intensive Care. 2022 May 23;12(1):44. doi: 10.1186/s13613-022-01017-5.
PubMed 35599248Scharf C, Liebchen U, Paal M, Taubert M, Vogeser M, Irlbeck M, Zoller M, Schroeder I. The higher the better? Defining the optimal beta-lactam target for critically ill patients to reach infection resolution and improve outcome. J Intensive Care. 2020 Nov 23;8(1):86. doi: 10.1186/s40560-020-00504-w.
PubMed 33292582
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness
- ClinicalTrials.gov ID
- NCT03985605
- Acronym / sponsor ID
- TAPSI / LMU 18-578
- Conditions
- Infection, Bacterial
- Keywords
- TDM, Routine, intensive care patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 14 Jun 2019 (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.
Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.
Detailed description
Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill intensive care patients who were included in the routines TDM-program since January 2018.
Key inclusion criteria (1 listed)
- routines TDM of antiinfectives
Key exclusion criteria (1 listed)
- TDM is not available
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
Incidence of subtherapeutic antiinfective concentrations
Time frame: four years
Number of subtherapeutic concentrations from different antiinfectives in critically ill patients
Correlation of meropenem concentration in serum to the concentration in brain fluid
Time frame: during the treatment with an external ventricular drainage
The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration
Subtherapeutic antiinfective concentrations during hemoadsorption
Time frame: during hemoadsorption treatment
Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment
5 secondary outcomes
28-day mortality of patients with therapeutic drug monitoring of antiinfectives
Time frame: during intensive care treatment
ICU-free days of patients with therapeutic drug monitoring of antiinfectives
Time frame: during intensive care treatment
Sofa-score course of patients with therapeutic drug monitoring of antiinfectives
Time frame: during the treatment with the antiinfectives
Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives
Time frame: during the treatment with the antiinfectives
Time course of CRP in patients with therapeutic drug monitoring of antiinfectives
Time frame: during the treatment with the antiinfectives
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 40279026Weber F, Scharf C, Aulin LBS, Weinelt F, Paal M, Mikus G, Vogeser M, Habler K, Huisinga W, Zoller M, Michelet R, Kloft C, Liebchen U. Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study. Infection. 2025 Oct;53(5):1819-1831. doi: 10.1007/s15010-025-02504-0. Epub 2025 Apr 25.
- Derived from this study: PubMed 35599248Scharf C, Weinelt F, Schroeder I, Paal M, Weigand M, Zoller M, Irlbeck M, Kloft C, Briegel J, Liebchen U. Does the cytokine adsorber CytoSorb(R) reduce vancomycin exposure in critically ill patients with sepsis or septic shock? a prospective observational study. Ann Intensive Care. 2022 May 23;12(1):44. doi: 10.1186/s13613-022-01017-5.
- Derived from this study: PubMed 33292582Scharf C, Liebchen U, Paal M, Taubert M, Vogeser M, Irlbeck M, Zoller M, Schroeder I. The higher the better? Defining the optimal beta-lactam target for critically ill patients to reach infection resolution and improve outcome. J Intensive Care. 2020 Nov 23;8(1):86. doi: 10.1186/s40560-020-00504-w.
- Individual participant dataSharing planned: No. sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)
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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. This study is not recruiting at the moment.
Bruegel Mathias, Dr. med. principal investigator
Institute of Laboratory Medicine of the University Hospital of Munich
Liebchen Uwe, Dr.med. study chair
Department of Anaesthesiology of the University Hospital of Munich
Ines Schroeder, Dr.med. study chair
Department of Anaesthesiology of the University Hospital of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bacterial, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of subtherapeutic antiinfective concentrations (time frame: four years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985605, which also lists 3 linked publications.
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 1 Jun 2022.