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TDM-optimized Teicoplanin Dosing Versus Standard of Care

TDM-optimized Teicoplanin Dosing Versus Standard of Care

Recruiting
18 years and older
All
Phase 4

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Overview

Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.

Description

Teicoplanin is a glycopeptide antibiotic that is frequently used in the treatment of gram-positive bacterial infections.

The glycopeptide antibiotic vancomycin is currently the first choice of treatment against methicillin-resistant Staphylococcus aureus (MRSA), but teicoplanin is found to have a similar efficacy while showing less nephrotoxicity (4.8% vs 10.7%). Vancomycin dosing is based on therapeutic drug monitoring (TDM). In contrast to vancomycin, value of TDM for teicoplanin is not as well defined. In this study the superiority of teicoplanin TDM-optimized dosing using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment will be investigated. The overall aim of this research is to improve antibiotic treatment with teicoplanin to allow safe and optimal treatment of glycopeptide susceptible strains and to prevent de novo development of resistance.

Eligibility

Inclusion Criteria:

  1. The patient is admitted to the ICU, haematology, gastroenterology or orthopaedics department.
  2. The patient is at least 18 years old on the day of inclusion.
  3. The patient is treated with teicoplanin as part of standard care.
  4. The patient or a representative is willing to sign the Informed Consent Form

Exclusion Criteria:

  1. The patient has previously participated in this study.
  2. The patient receives any form of renal replacement criteria (RRT) other than CVVHD / CVVHDF.
  3. Expected duration of teicoplanin therapy is less than 5 days.
  4. The patient is pregnant

Study details
    Bacterial Infections

NCT05914467

Radboud University Medical Center

30 April 2024

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