VancomycinNCT05964114
First Time Right of Vancomycin
A study testing Vancomycin in people with Vancomycin and Pharmacokinetics, run by Erasmus Medical Center.
Trial summary
In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin, Pharmacokinetics
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jun 2026
- Phase
- Interventional
- 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
- Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
- Patient or their legal representative is able and willing to sign the Informed Consent Form
Who cannot join
- Pregnant woman
- Children
- Patients with a transplantation history
- Patients on continuous renal replacement therapy (CRRT)
- Patients receiving extracorporeal membrane oxygenation (ECMO)
About this study
Official title: Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.
In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.
In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.
- Conditions
- Vancomycin, Pharmacokinetics
- Being tested
- Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).
| Study group | Role | What they receive |
|---|---|---|
| Starting dose of vancomycin standard vs MIPD | Experimental | Comparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models). Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.
The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VancomycinStudies of the same condition, open and under way.
- More trials run by Erasmus 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiaan D.T. Sassen, PharmD PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964114
- Sponsor's protocol ID
- 7646
- Status last verified
- Jul 2023
- First submitted
- 24 Jan 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.
- ClinicalTrials.gov ID
- NCT05964114
- Acronym / sponsor ID
- 7646
- Conditions
- Vancomycin, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Jul 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.
In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.
In a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Starting dose of vancomycin standard vs MIPD | Experimental | Drug: VancomycinComparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department
- Patient or their legal representative is able and willing to sign the Informed Consent Form
Key exclusion criteria (5 listed)
- Pregnant woman
- Children
- Patients with a transplantation history
- Patients on continuous renal replacement therapy (CRRT)
- Patients receiving extracorporeal membrane oxygenation (ECMO)
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 |
|---|---|---|
| VancomycinInitial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range). | Drug | Starting dose of vancomycin standard vs MIPD |
Primary outcome
Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.
Time frame: two years
The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vancomycin in people with Vancomycin and Pharmacokinetics, run by Erasmus Medical Center.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment. (time frame: two years). 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 27 Jul 2023; AzTrials last refreshed its copy on 3 Nov 2026.