TDM-optimized Teicoplanin Dosing Versus Standard of Care (PLATO-3)

Radboud University Medical Center

Status and phase: Enrolling; Phase 4

Conditions: Bacterial Infections

Treatments: Drug: Teicoplanin

Study type: Interventional

Funder types: Other

Identifiers

NCT05914467

2023-503411-15-00 (Other Identifier)

113998

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Participants receive teicoplanin on discretion of the doctor

Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM)

Experimental group

Description:

Participants start on standard of care dosing. After 2 days blood samples will be analysed and exposure will be determined using MIPD. Wherever necessary dose adjustments will be made.

Treatment:

Drug: Teicoplanin