Bacterial InfectionsPhase 4PLATO-3NCT05914467
TDM-optimized Teicoplanin Dosing Versus Standard of Care
A Phase 4 study testing Teicoplanin in people with Bacterial Infections, run by Radboud University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Teicoplanin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2023to 20 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care
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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Teicoplanin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeicoplaninDrug
Dose will be adjusted in the study arm using MIPD guided TDM- dosing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Teicoplanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5-7 days after initiation of teicoplanin therapy
Secondary outcomes (3)
Time until reaching target attainment
Time until a participant reaches the therapeutic window will be estimated using the MIPD
Measured: 5-7 days after initiation of teicoplanin therapy
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
Measured: 30 days after initiation of teicoplanin therapy
Days in hospital
Total number of days in the hospital
Measured: 30 days after initiation of teicoplanin therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Aug 2023
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Why it stopped: The intervention was deemed futile the intervention group, as TDM was not needed in patients with a 12mg/kg dose. In consultation with the METC and biostatistics it was decided to terminate the study early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Nynke Jager, Principal investigator, Radboud university medical center (Radboudumc)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914467
- Sponsor's protocol ID
- 113998
- Other IDs
- 2023-503411-15-00, 2023
- Acronym
- PLATO-3
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Investigating the Superiority of TDM-optimized Teicoplanin Dosing Versus Standard of Care
- ClinicalTrials.gov ID
- NCT05914467
- Acronym / sponsor ID
- PLATO-3 / 113998
- Conditions
- Bacterial Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The intervention was deemed futile the intervention group, as TDM was not needed in patients with a 12mg/kg dose. In consultation with the METC and biostatistics it was decided to terminate the study early.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 between standard treatment and treatment guided by TDM with MIPD.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Participants receive teicoplanin on discretion of the doctor |
| Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM) | Experimental | Drug: TeicoplaninParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeicoplaninDose will be adjusted in the study arm using MIPD guided TDM- dosing | Drug | Model Informed Precision Dosing (MIPD) guided Therapeutic Drug Monitoring(TDM) |
Primary outcome
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
3 secondary outcomes
Time until reaching target attainment
Time frame: 5-7 days after initiation of teicoplanin therapy
Clinical failure
Time frame: 30 days after initiation of teicoplanin therapy
Days in hospital
Time frame: 30 days after initiation of teicoplanin therapy
Results and safety
The study was stopped early (reason given: The intervention was deemed futile the intervention group, as TDM was not needed in patients with a 12mg/kg dose. In consultation with the METC and biostatistics it was decided to terminate the study early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nynke Jager principal investigator
Radboud university medical center (Radboudumc)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teicoplanin in people with Bacterial Infections, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The intervention was deemed futile the intervention group, as TDM was not needed in patients with a 12mg/kg dose. In consultation with the METC and biostatistics it was decided to terminate the study early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of participants that reaches therapeutic exposure after 5 days of treatment (time frame: 5-7 days after initiation of teicoplanin therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.