TDM-optimized Teicoplanin Dosing Versus Standard of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

Participants receive teicoplanin on discretion of the doctor

Group Type NO_INTERVENTION

No interventions assigned to this group

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

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.

Group Type EXPERIMENTAL

Teicoplanin

Intervention Type DRUG

Dose will be adjusted in the study arm using MIPD guided TDM- dosing

Interventions

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Teicoplanin

Dose will be adjusted in the study arm using MIPD guided TDM- dosing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No