NCT05914467

TDM-optimized Teicoplanin Dosing Versus Standard of Care

A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Teicoplanin	Dose will be adjusted in the study arm using MIPD guided TDM- dosing

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2023-06-22
• Last updated: 2026-02-18

Locations

1 site across 1 country: Netherlands