TDM-optimized Teicoplanin Dosing Versus Standard of Care

NCT05914467 | Active Not Recruiting Phase 4

• 2 other identifiers: 1139982023-503411-15-00
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time until reaching target attainment

  5-7 days after initiation of teicoplanin therapy

• Clinical failure

  30 days after initiation of teicoplanin therapy

• Days in hospital

  30 days after initiation of teicoplanin therapy

Other Outcomes (1)

• Acute Kidney Injury (AKI)

  30 days after initiation of teicoplanin therapy

Study Arms (2)

Standard of care

NO INTERVENTION

Participants receive teicoplanin on discretion of the doctor

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

EXPERIMENTAL

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

Interventions

Teicoplanin DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is admitted to the ICU, haematology, gastroenterology or orthopaedics department.
• The patient is treated with teicoplanin as part of standard care.
• The patient or a representative is willing to sign the Informed Consent Form

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

RadboudUMC

Nijmegen, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Teicoplanin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipoglycopeptides; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nynke Jager

  Radboud university medical center (Radboudumc)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)