TDM-optimized Teicoplanin Dosing Versus Standard of Care

Phase 4Active Not RecruitingNCT05914467

Radboud University Medical Center74 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Infections

Interventions

TeicoplaninDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

RadboudUMC

Nijmegen, Netherlands

Outcomes

Primary Outcomes

Fraction of participants that reaches therapeutic exposure after 5 days of treatment

Unbound teicoplanin exposure after 5 days will be determined and compared to the predefined therapeutic window of 70-150 mg/L\*24h

Time frame: 5-7 days after initiation of teicoplanin therapy

Secondary Outcomes

Time until reaching target attainment

Time until a participant reaches the therapeutic window will be estimated using the MIPD

Time frame: 5-7 days after initiation of teicoplanin therapy

Clinical failure

Incidence of clinical failure at day 30. Incidence of clinical failure of teicoplanin treatment will be defined as occurrence of one of the following on day 30: * Persistent bacteremia * Uncontrolled infection at the site of infection by the pathogen for which teicoplanin treatment was started * Escalation of therapy * Switch of antimicrobial therapy due to lack of effectiveness of teicoplanin

Time frame: 30 days after initiation of teicoplanin therapy

Days in hospital

Total number of days in the hospital

Time frame: 30 days after initiation of teicoplanin therapy

Data from ClinicalTrials.gov

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