Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI (TAPSI)

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.

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Department of Anaesthesiology of the University Hospital of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill intensive care patients who were included in the routines TDM-program since January 2018.

Description

Inclusion Criteria:

• routines TDM of antiinfectives

Exclusion Criteria:

• TDM is not available

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subtherapeutic antiinfective concentrations	Number of subtherapeutic concentrations from different antiinfectives in critically ill patients	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	during the treatment with an external ventricular drainage
Subtherapeutic antiinfective concentrations during hemoadsorption	Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment	during hemoadsorption treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality of patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations in serum to 28-day mortality	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	during intensive care treatment
Sofa-score course of patients with therapeutic drug monitoring of antiinfectives	Correlation of antiinfective concentrations in serum to sofa-score	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	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	during the treatment with the antiinfectives

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: 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 Chair: Lesca Holdt, 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

Publications and helpful links

General Publications

• Scharf C, Weinelt F, Schroeder I, Paal M, Weigand M, Zoller M, Irlbeck M, Kloft C, Briegel J, Liebchen U. Does the cytokine adsorber CytoSorb(®) 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.
• Scharf 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 12, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: TDM; Routine; intensive care patients
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: LMU 18-578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No