Bacterial Infections
Conditions
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.
Interventions
DRUGTeicoplanin
Dose will be adjusted in the study arm using MIPD guided TDM- dosing
Sponsors
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of participants that reaches therapeutic exposure after 5 days of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Time until reaching target attainment | 5-7 days after initiation of teicoplanin therapy | Time until a participant reaches the therapeutic window will be estimated using the MIPD |
| Clinical failure | 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 |
| Days in hospital | 30 days after initiation of teicoplanin therapy | Total number of days in the hospital |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORNynke Jager
Radboud university medical center (Radboudumc)
Outcome results
None listed