VancomycinPhase 4NCT05535075
Model-informed Precision Dosing of Vancomycin in Adults
A Phase 4 study testing Vancomycin model-informed precision dosing and Vancomycin in people with Vancomycin, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vancomycin
- What is being tested?
- Vancomycin model-informed precision dosing and Vancomycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 Nov 2021to 17 Nov 2023
- 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
- 18 years or older
- admitted to a participating ward unit
- a suspected or confirmed Gram positive infection
- planned to start of started on intravenous continuous infusion vancomycin treatment
- participant or legal representative signed the informed consent form
- not previously enrolled in this trial
Who cannot join
- serum creatinine level at inclusion is above 2.5 mg/dL
- undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
- patient death is deemed imminent and inevitable.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
General Hospital Sint-Jan Brugge
Bruges
Ghent University Hospital
Ghent
About this study
Official title: Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial
The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
Read the detailed description
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the individual patient is challenging.
Currently, the vancomycin dose is adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in non-critically ill adults, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney and a reduction in patient burden.
- Conditions
- Vancomycin
- Being tested
- Vancomycin model-informed precision dosing, Vancomycin
- Keywords
- vancomycin, model-informed precision dosing, dose calculator, non-critically ill adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin model-informed precision dosingDevice
Also called Dosing calculator
A dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L
VancomycinDrug
Also called Vancomycin treatment
Vancomycin treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Vancomycin treatment | Active comparator | Vancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period Receives: Drug: Vancomycin |
| Vancomycin model-informed precision dosing | Experimental | Area Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period Receives: Device: Vancomycin model-informed precision dosing; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching target 24h AUC/MIC
Therapeutic AUC/MIC target range is 400-600
Measured: 48 to 72 hours after start vancomycin treatment
Secondary outcomes (3)
Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment
AKI categories are defined according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria from stage 1 to 3 (worst)
Measured: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
Therapeutic AUC/MIC target range is 400-600
Measured: 72 to 96 hours after start vancomycin treatment
Proportion of time within therapeutic target
Therapeutic AUC/MIC target range is 400-600
Measured: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start12 Nov 2021
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pieter De Cock, Prof, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535075
- Sponsor's protocol ID
- BC-10433
- Other IDs
- 2021-003670-31
- Status last verified
- Nov 2023
- First submitted
- 13 May 2022
- Last updated
- 1 Dec 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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Model-informed Precision Dosing of Vancomycin in Adults: a Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT05535075
- Acronym / sponsor ID
- BC-10433
- Conditions
- Vancomycin
- Keywords
- vancomycin, model-informed precision dosing, dose calculator, non-critically ill adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 10 Sep 2022 (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.
The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.
Detailed description
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the individual patient is challenging.
Currently, the vancomycin dose is adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in non-critically ill adults, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney and a reduction in patient burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Vancomycin treatment | Active comparator | Drug: VancomycinVancomycin standard-of-care dosing and therapeutic drug monitoring (TDM), according to institutional guidelines during 20 day study period |
| Vancomycin model-informed precision dosing | Experimental | Device: Vancomycin model-informed precision dosing, Drug: VancomycinArea Under the Concentration-time curve ((AUC)/Minimal Inhibitory Concentration (MIC)-based model-informed precision dosing of vancomycin using a dosing calculator during 20 day study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- admitted to a participating ward unit
- a suspected or confirmed Gram positive infection
- planned to start of started on intravenous continuous infusion vancomycin treatment
- participant or legal representative signed the informed consent form
Key exclusion criteria (3 listed)
- serum creatinine level at inclusion is above 2.5 mg/dL
- undergoing extracorporeal treatment at inclusion (e.g. extracorporeal membrane oxygenation, dialysis, body cooling)
- patient death is deemed imminent and inevitable.
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 |
|---|---|---|
| Vancomycin model-informed precision dosingAlso: Dosing calculatorA dosing calculator is used for a posteriori calculation of vancomycin dose using a target AUC/MIC between 400-600 mg*h/L | Device | Vancomycin model-informed precision dosing |
| VancomycinAlso: Vancomycin treatmentVancomycin treatment | Drug | Standard of Care Vancomycin treatment, Vancomycin model-informed precision dosing |
Primary outcome
Proportion of patients reaching target 24h AUC/MIC
Time frame: 48 to 72 hours after start vancomycin treatment
Therapeutic AUC/MIC target range is 400-600
3 secondary outcomes
Proportion of patients with (worsening) acute kidney injury (AKI) during vancomycin treatment
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
Proportion of patients reaching target 24h AUC/MIC
Time frame: 72 to 96 hours after start vancomycin treatment
Proportion of time within therapeutic target
Time frame: From start date of vancomycin treatment until stop date vancomycin treatment or study day 20, whichever comes first
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 1 Dec 2023.
Related trials for Vancomycin
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Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
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RecruitingPhase 4
The Vancomycin Piperacillin/Tazobactam (VPT) Patient Safety Trial (VPS)
Infection, Acute Kidney Injury
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
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RecruitingPhase 2
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis
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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.
Pieter De Cock, Prof principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin model-informed precision dosing and Vancomycin in people with Vancomycin, run by University Hospital, Ghent at 2 sites in Belgium.
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 6 inclusion and 3 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 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?
Proportion of patients reaching target 24h AUC/MIC (time frame: 48 to 72 hours after start vancomycin treatment). 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 1 Dec 2023.