Bacterial InfectionsPLATONCT04096092
Pharmacokinetics of Teicoplanin in Intensive Care and Haematology Patients
An observational study of Bacterial Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function. In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jan 2020to 1 Dec 2022
- Phase
- Observational
- 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
Study population: All critically ill patients (defined as ICU and hematology patients) with a suspected or proven bacterial infection who are already treated with teicoplanin as a part of routine clinical care are eligible for inclusion. A total of 30 patients will be included.
Who may be able to join
- The patient is admitted to the ICU of the haematology department
- The patient is at least 18 years of age on the day of inclusion
- Is managed with a central venous catheter or arterial line
- Is treated with teicoplanin as a part of standard care
Who cannot join
- Has previously participated in this study
- Patient is admitted to the haematology department and receives any form of RRT other than continuous venovenous hemofiltration (CVVH).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Population PK Study Into Teicoplanin in Intensive Care and Haematology Patients - a Strategy Towards Model Informed Precision Dosing
Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function.
In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.
Read the detailed description
Bacterial infection with coagulase-negative staphylococci (CNS) or methicillin resistant and sensitive staphylococcus aureus(MRSA/MSSA) indicates poor prognosis and increased mortality in critically ill patients.
With the current emergence of glycopeptide-intermediate sensitive Staphylococcus aureus strains, personalized dosing of teicoplanin is of utmost importance to preserve the current therapeutic armamentarium.
Teicoplanin is considered equipotent to vancomycin, albeit safer with minimal nephrotoxicity. It is estimated that 50% of all critically ill patients treated with teicoplanin does not reach target exposure. This is the major driver for treatment failure and development of resistance and dose individualization will overcome this problem.
Our project is aimed at developing and implementing a personalized dosing strategy for teicoplanin, to prevent development of glycopeptide resistance and allow safe treatment of glycopeptide intermediate sensitive bacteria.
In a prospective clinical study, critically ill patients (defined as ICU and hematology patients) who receive teicoplanin as standard care for antimicrobial treatment will be eligible for inclusion. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through an indwelling central venous catheter or an arterial line (9 samples per patient). Teicoplanin total and free drug concentrations will be measured using a validated analytical assay. A total of 30 patients will be included.
We will develop a population PK model using nonlinear mixed effects modelling for total and unbound teicoplanin to characterize the magnitude of inter-individual variability in PK parameters (clearance, distribution volume), and to identify patient-derived characteristics that can predict such variability in a critically ill patient population.
- Conditions
- Bacterial Infections
- Being tested
- No intervention
- Keywords
- Teicoplanin, Pharmacokinetics, Critically ill
- Medical subject headings
- Bacterial Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Total drug clearance
Pharmacokinetic curves will be taken
Measured: 4 days
Secondary outcomes (2)
Volume of distribution
Pharmacokinetic curves will be taken
Measured: 4 days
Area under the curve
Pharmacokinetic curves will be taken
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start15 Jan 2020
- Primary completion19 Oct 2021
- Study completion1 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096092
- Sponsor's protocol ID
- UMCN-AKF 19.05
- Acronym
- PLATO
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2019
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population PK Study Into Teicoplanin in Intensive Care and Haematology Patients - a Strategy Towards Model Informed Precision Dosing
- ClinicalTrials.gov ID
- NCT04096092
- Acronym / sponsor ID
- PLATO / UMCN-AKF 19.05
- Conditions
- Bacterial Infections
- Keywords
- Teicoplanin, Pharmacokinetics, Critically ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 19 Sep 2019 (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.
Characterize teicoplanin PK in critically ill patients with a specific focus on alterations of exposure due to variability in renal function.
In a prospective, observational, open-label study the investigators aim to define PK of free drug concentrations of teicoplanine in ICU and heamatology patients and define a PK model for Bayesian dose individualization.
Detailed description
Bacterial infection with coagulase-negative staphylococci (CNS) or methicillin resistant and sensitive staphylococcus aureus(MRSA/MSSA) indicates poor prognosis and increased mortality in critically ill patients.
With the current emergence of glycopeptide-intermediate sensitive Staphylococcus aureus strains, personalized dosing of teicoplanin is of utmost importance to preserve the current therapeutic armamentarium.
Teicoplanin is considered equipotent to vancomycin, albeit safer with minimal nephrotoxicity. It is estimated that 50% of all critically ill patients treated with teicoplanin does not reach target exposure. This is the major driver for treatment failure and development of resistance and dose individualization will overcome this problem.
Our project is aimed at developing and implementing a personalized dosing strategy for teicoplanin, to prevent development of glycopeptide resistance and allow safe treatment of glycopeptide intermediate sensitive bacteria.
In a prospective clinical study, critically ill patients (defined as ICU and hematology patients) who receive teicoplanin as standard care for antimicrobial treatment will be eligible for inclusion. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through an indwelling central venous catheter or an arterial line (9 samples per patient). Teicoplanin total and free drug concentrations will be measured using a validated analytical assay. A total of 30 patients will be included.
We will develop a population PK model using nonlinear mixed effects modelling for total and unbound teicoplanin to characterize the magnitude of inter-individual variability in PK parameters (clearance, distribution volume), and to identify patient-derived characteristics that can predict such variability in a critically ill patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All critically ill patients (defined as ICU and hematology patients) with a suspected or proven bacterial infection who are already treated with teicoplanin as a part of routine clinical care are eligible for inclusion. A total of 30 patients will be included.
Key inclusion criteria (4 listed)
- The patient is admitted to the ICU of the haematology department
- The patient is at least 18 years of age on the day of inclusion
- Is managed with a central venous catheter or arterial line
- Is treated with teicoplanin as a part of standard care
Key exclusion criteria (2 listed)
- Has previously participated in this study
- Patient is admitted to the haematology department and receives any form of RRT other than continuous venovenous hemofiltration (CVVH).
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Total drug clearance
Time frame: 4 days
Pharmacokinetic curves will be taken
2 secondary outcomes
Volume of distribution
Time frame: 4 days
Area under the curve
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bacterial Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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: finished, as of the sponsor's last update on 31 Jan 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total drug clearance (time frame: 4 days). 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 31 Jan 2023.