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NCT Number: NCT05914467

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RadboudUMC

Nijmegen, 6525GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is admitted to the ICU, haematology, gastroenterology or orthopaedics department.
  • The patient is at least 18 years old on the day of inclusion.
  • The patient is treated with teicoplanin as part of standard care.
  • The patient or a representative is willing to sign the Informed Consent Form

Exclusion criteria

  • The patient has previously participated in this study.
  • The patient receives any form of renal replacement criteria (RRT) other than CVVHD / CVVHDF.
  • Expected duration of teicoplanin therapy is less than 5 days.
  • The patient is pregnant

Treatment and study plan

Teicoplanin

Drug

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Time until reaching target attainment

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

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

  2. Clinical failure

    Time frame: 30 days after initiation of teicoplanin therapy

    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

  3. Days in hospital

    Time frame: 30 days after initiation of teicoplanin therapy

    Total number of days in the hospital

Other outcomes

  1. Acute Kidney Injury (AKI)

    Time frame: 30 days after initiation of teicoplanin therapy

    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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: PLATO-3

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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