Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI (TAPSI)
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ClinicalTrials.gov Identifier: NCT03985605 |
Recruitment Status :
Recruiting
First Posted : June 14, 2019
Last Update Posted : September 2, 2020
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Condition or disease |
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Infection, Bacterial |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness |
Actual Study Start Date : | January 1, 2018 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
- 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
- 28-day mortality of patients with therapeutic drug monitoring of antiinfectives [ Time Frame: during intensive care treatment ]Correlation of antiinfective concentrations in serum to 28-day mortality
- ICU-free days of patients with therapeutic drug monitoring of antiinfectives [ Time Frame: during intensive care treatment ]Correlation of antiinfective concentrations in serum to ICU-free days to day 28
- Sofa-score course of patients with therapeutic drug monitoring of antiinfectives [ Time Frame: during the treatment with the antiinfectives ]Correlation of antiinfective concentrations in serum to sofa-score
- Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives [ Time Frame: during the treatment with the antiinfectives ]Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients
- Time course of CRP in patients with therapeutic drug monitoring of antiinfectives [ Time Frame: during the treatment with the antiinfectives ]Correlation of antiinfective concentrations to CRP in critically ill patients

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- routines TDM of antiinfectives
Exclusion Criteria:
- TDM is not available

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985605
Contact: Michael Zoller, Dr. med. | +4915254849023 | michael.zoller@med.uni-muenchen.de | |
Contact: Christina Scharf, Dr.med. | +49 1525 484 8978 | christina.scharf@med.uni-muenchen.de |
Germany | |
Department of Anaesthesiology of the University Hospital of Munich | Recruiting |
Munich, Germany, 81377 | |
Contact: Michael Zoller, Dr. med. +498944000 michael.zoller@med.uni-muenchen.de | |
Principal Investigator: Michael Zoller, Dr. med. |
Principal Investigator: | Bruegel Mathias, Dr. med. | Institute of Laboratory Medicine of the University Hospital of Munich | |
Study Chair: | Liebchen Uwe, Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | |
Study Chair: | Ines Schroeder, Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | |
Study Chair: | Paal Michael, Dr.rer.nat. | Institute of Laboratory Medicine of the University Hospital of Munich | |
Study Director: | Bernhard Zwissler, Prof.Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | |
Study Director: | Daniel Teupser, Prof.Dr.med. | Institute of Laboratory Medicine of the University Hospital of Munich | |
Study Chair: | Lesca Holdt, Prof.Dr.med. | Institute of Laboratory Medicine of the University Hospital of Munich | |
Study Chair: | Michael Vogeser, Prof.Dr.med. | Institute of Laboratory Medicine of the University Hospital of Munich | |
Study Chair: | Eike Speck | Department of Anaesthesiology of the University Hospital of Munich | |
Study Chair: | Michael Irlbeck, PD.Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | |
Study Chair: | Thomas Weig, PD.Dr.med. | Department of Anaesthesiology of the University Hospital of Munich |
Responsible Party: | Michael Zoller MD, Principal Investigator, Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT03985605 |
Other Study ID Numbers: |
LMU 18-578 |
First Posted: | June 14, 2019 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR) |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
TDM Routine intensive care patients |
Bacterial Infections |