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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 : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Zoller MD, Ludwig-Maximilians - University of Munich

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.

Condition or disease
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.

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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



Primary Outcome Measures :
  1. Incidence of subtherapeutic antiinfective concentrations [ Time Frame: four years ]
    Number of subtherapeutic concentrations from different antiinfectives in critically ill patients

  2. 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

  3. Subtherapeutic antiinfective concentrations during hemoadsorption [ Time Frame: during hemoadsorption treatment ]
    Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
Study Population
Critically ill intensive care patients who were included in the routines TDM-program since January 2018.
Criteria

Inclusion Criteria:

  • routines TDM of antiinfectives

Exclusion Criteria:

  • TDM is not available

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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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

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Responsible Party: Michael Zoller MD, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT03985605     History of Changes
Other Study ID Numbers: LMU 18-578
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Zoller MD, Ludwig-Maximilians - University of Munich:
TDM
Routine
intensive care patients
Additional relevant MeSH terms:
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Bacterial Infections
Anti-Infective Agents