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

NCT03985605 | Completed DMC

• 1 other identifier: LMU 18-578
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.

Conditions

Infection, Bacterial

Keywords

TDM; Routine; intensive care patients

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 28-day mortality of patients with therapeutic drug monitoring of antiinfectives

  during intensive care treatment

• ICU-free days of patients with therapeutic drug monitoring of antiinfectives

  during intensive care treatment

• Sofa-score course of patients with therapeutic drug monitoring of antiinfectives

  during the treatment with the antiinfectives

• Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives

  during the treatment with the antiinfectives

• Time course of CRP in patients with therapeutic drug monitoring of antiinfectives

  during the treatment with the antiinfectives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• routines TDM of antiinfectives

You may not qualify if:

• TDM is not available

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

Location

Related Publications (3)

• 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.

  PMID: 40279026 DERIVED

• 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(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.

  PMID: 35599248 DERIVED

• 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.

  PMID: 33292582 DERIVED

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Bruegel Mathias, Dr. med.

  Institute of Laboratory Medicine of the University Hospital of Munich

  PRINCIPAL INVESTIGATOR

• 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

• 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 DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: June 14, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)