A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Fraction of participants that reaches therapeutic exposure after 5 days of treatment
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel assignment
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Teicoplanin (Drug)
Standard of care
Participants receive teicoplanin on discretion of the doctor
Outcomes
Primary Outcomes
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
- Time until reaching target attainment(5-7 days after initiation of teicoplanin therapy)
- Days in hospital(30 days after initiation of teicoplanin therapy)
- Clinical failure(30 days after initiation of teicoplanin therapy)
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT05914467
- Other Study IDs
- 113998, 2023-503411-15-00
Dates
- First Submitted
- (3 years ago)
- First Posted
- (3 years ago)
- Primary Completion
- (7 months ago)
- Study Completion
- (7 months ago)
- Last Verified
- (last year)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No