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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Teicoplanin

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525GA
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Participants receive teicoplanin on discretion of the doctor
Experimental: 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.	Drug: Teicoplanin; Dose will be adjusted in the study arm using MIPD guided TDM- dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5-7 days after initiation of teicoplanin therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until reaching target attainment	Time until a participant reaches the therapeutic window will be estimated using the MIPD	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	30 days after initiation of teicoplanin therapy
Days in hospital	Total number of days in the hospital	30 days after initiation of teicoplanin therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Kidney Injury (AKI)	incidence of AKI during teicoplanin treatment. Occurrence of nephrotoxicity will be defined as a binary denominator complying to any of the following markers according to the Kidney Disease: Improving Global Outcomes (KDIGO) guideline for acute kidney injury.; Increase in serum creatinine of > 0.3 mg/dl within 48 hours; Increase in serum creatinine to > 1.5 times baseline, which is known or presumed to have occurred within the prior 7 day	30 days after initiation of teicoplanin therapy

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Nynke Jager, Radboud University Medical Center (Radboudumc)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Peptides; Amino Acids, Peptides, and Proteins; Carbohydrates; Glycoconjugates; Glycopeptides; Lipoglycopeptides; Teicoplanin
• Other Study ID Numbers: 113998; 2023-503411-15-00 (Other Identifier: EU CT-number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No