Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503411-15-00 | Other Identifier | EU CT-number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teicoplanin | Drug | Dose will be adjusted in the study arm using MIPD guided TDM- dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical failure |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nynke Jager | Radboud university medical center (Radboudumc) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RadboudUMC | Nijmegen | 6525GA | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017334 | Teicoplanin |
| ID | Term |
|---|---|
| D000077427 | Lipoglycopeptides |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
Not provided
Not provided
Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.
Not provided
Not provided
Not provided
Not provided
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:
| 30 days after initiation of teicoplanin therapy |
| Days in hospital | Total number of days in the hospital | 30 days after initiation of teicoplanin therapy |
| 30 days after initiation of teicoplanin therapy |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |