TDM-optimized Teicoplanin Dosing Versus Standard of Care

Bacterial Infections Clinical Trial

— PLATO-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914467
• Other study ID #: 113998
• Secondary ID: 2023-503411-15-0
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: jaap Mouton
• Phone: 0031 24 361 9191
• Email: jaap.mouton[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• Teicoplanin
Dose will be adjusted in the study arm using MIPD guided TDM- dosing

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Days in hospital	Total number of days in the hospital	30 days after initiation of teicoplanin therapy