Plasma ConcentrationFREEVANCONCT07043673
Plasma Concentrations of the Non-protein-bound Form of Vancomycin
An observational study of Plasma Concentration, run by University Hospital, Rouen at 1 site in France.
Trial summary
In routine practice, the use of vancomycin must be accompanied by plasma concentration monitoring to ensure that pharmacodynamic targets are met and that plasma concentrations are not in toxic ranges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasma Concentration
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2022to 1 Mar 2025
- How long will I take part?
- 2 Months
- 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: This study concerns any intensive care patient at the Rouen University Hospital undergoing a plasma vancomycin dosage carried out as part of routine care for a suspected or proven Gram + cocci infection.
Who may be able to join
- Adult patient hospitalized in intensive care,
- Treated with vancomycin for a proven or suspected Gram-positive cocci infection,
- For whom a plasma vancomycin dose has been prescribed
- Patient who has been informed and has expressed verbal non-opposition. If the patient is unable to express their non-opposition (emergency situations), non-opposition must be obtained from the patient's representative, their trusted person, or, failing that, a relative.
Who cannot join
- Objection from the patient or their relatives
- Discontinuous administration of vancomycin
- Total plasma vancomycin levels measured 5 days or more prior to inclusion, with the plasma sample being stored in the laboratory for only 5 days, as is standard practice.
- Individuals not covered by a social security scheme
- Failure to perform the prescribed vancomycin dosage: discontinuation of vancomycin, death, etc.
- Vancomycin serum sample taken before the 24th hour, including the loading dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plasma Concentrations of the Non-protein-bound Form of Vancomycin in Intensive Care
In routine practice, the use of vancomycin must be accompanied by plasma concentration monitoring to ensure that pharmacodynamic targets are met and that plasma concentrations are not in toxic ranges.
Because vancomycin has high plasma protein binding and a free fraction exhibits marked inter-individual variability, this variability is increased in intensive care, monitoring is all the more imperative.
Read more
The factors influencing the concentration and/or free fraction of vancomycin are numerous and vary from one study to another. The striking fact of this work is that the link between the concentration of the total form and the concentration of the free form has not been established.
However, only plasma measurements of the total form of vancomycin are currently available to clinicians in routine practice, while only the free fraction is biologically active, responsible for its efficacy, but also for its toxicity in the event of an overdose. This paradox is widely highlighted by authors who have studied the free fraction of vancomycin, emphasizing the importance of continuing scientific research on this subject. Moreover, these studies are few in number, particularly in intensive care units, and their sample size is small, and they present biases, particularly those related to their essentially retrospective nature.
The failure to consider the free concentration of vancomycin in the therapeutic monitoring strategy is primarily explained by the fact that clinicians do not have access to plasma concentrations of the free form of drugs in routine practice. Thus, the guidelines do not include pharmacodynamic targets for the free concentration, due to the lack of scientific data on the subject.
Read the detailed description
Since 2019, the Rouen University Hospital Pharmacology Laboratory has been measuring the non-protein-bound plasma concentrations of certain beta-lactam antibiotics. The analyzed sample comes from ultrafiltration of the plasma sample, a pre-analytical technique used in several studies on the free form of vancomycin. Access to this new technique at Rouen University Hospital gives us the opportunity to study free vancomycin concentrations in ICU patients.
This study therefore aims to investigate free vancomycin plasma concentrations in patients admitted to the ICU treated for suspected or proven Gram-positive cocci infection, and for whom a dosage has been prescribed as part of routine practice.
This prospective study aims to specifically analyze the concentration of the free form of vancomycin, but also to determine whether certain clinical or biological factors could predict this concentration. The long-term objective would be to be able to better individualize dosage regimens for vancomycin, a molecule with high inter-individual variability in intensive care patients, with the aim of reducing both underdoses, which are responsible for therapeutic failures, and overdoses, which are responsible for toxicity.
- Conditions
- Plasma Concentration
- Keywords
- vancomycine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin plasma dosage group | Any intensive care patient at the Rouen University Hospital undergoing a plasma vancomycin dosage carried out as part of routine care for a suspected or proven Gram + Cocci infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plasma concentration of the free form of vancomycin
The primary endpoint is determined by the measurement of the plasma concentration of the free form of vancomycin during the total plasma concentration measurement after at least 24 hours of continuous infusion treatment.
Measured: 24 hours after the start of continuous vancomycin infusion treatment
Secondary outcomes (5)
Measurement of the fraction of the non-protein-bound form of vancomycin in plasma
The fraction unbound to plasma proteins (free form) of vancomycin will be determined by the ratio of the concentration of the free form to that of the total form, and expressed as a %.
Measured: 24 hours
To determine the areas under the 24-hour curve (AUC24h) for total plasma protein-bound forms of vancomycin
The area under the 24-hour plasma concentration curve (AUC24h) is calculated for vancomycin by the product of the plasma concentration times 24, due to continuous administration. It is expressed in mg.h/L.
Measured: 24 hours
To compare the areas under the 24-hour curve (AUC24h) for total and non-plasma protein-bound forms of vancomycin
The area under the 24-hour plasma concentration curve (AUC24h) is calculated for vancomycin by the product of the plasma concentration times 24, due to continuous administration. It is expressed in mg.h/L.
Measured: 24 hours
To determine the areas under the 24-hour curve (AUC24h) for non-plasma protein-bound forms of vancomycin
The area under the 24-hour plasma concentration curve (AUC24h) is calculated for vancomycin by the product of the plasma concentration times 24, due to continuous administration. It is expressed in mg.h/L.
Measured: 24 hours
To assess the frequency of achieving vancomycin pharmacodynamic targets for its total plasma concentration
The pharmacodynamic objective of vancomycin will be considered to be achieved when the AUC24h/MIC of the total form is greater than or equal to 400, corresponding to a total vancomycinemia greater than 17 mg/L, for the treatment of a Staphylococcus sp with a MIC of 1 mg/L
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start17 Jun 2022
- Primary completion31 Aug 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma ConcentrationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe PG GOUIN, Professor, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043673
- Sponsor's protocol ID
- 2022/058/OB
- Other IDs
- N° IDRCB : 2022-A00706-37
- Acronym
- FREEVANCO
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Concentrations of the Non-protein-bound Form of Vancomycin in Intensive Care
- ClinicalTrials.gov ID
- NCT07043673
- Acronym / sponsor ID
- FREEVANCO / 2022/058/OB
- Conditions
- Plasma Concentration
- Keywords
- vancomycine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 29 Jun 2025 (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 routine practice, the use of vancomycin must be accompanied by plasma concentration monitoring to ensure that pharmacodynamic targets are met and that plasma concentrations are not in toxic ranges.
Because vancomycin has high plasma protein binding and a free fraction exhibits marked inter-individual variability, this variability is increased in intensive care, monitoring is all the more imperative.
The factors influencing the concentration and/or free fraction of vancomycin are numerous and vary from one study to another. The striking fact of this work is that the link between the concentration of the total form and the concentration of the free form has not been established.
However, only plasma measurements of the total form of vancomycin are currently available to clinicians in routine practice, while only the free fraction is biologically active, responsible for its efficacy, but also for its toxicity in the event of an overdose. This paradox is widely highlighted by authors who have studied the free fraction of vancomycin, emphasizing the importance of continuing scientific research on this subject. Moreover, these studies are few in number, particularly in intensive care units, and their sample size is small, and they present biases, particularly those related to their essentially retrospective nature.
The failure to consider the free concentration of vancomycin in the therapeutic monitoring strategy is primarily explained by the fact that clinicians do not have access to plasma concentrations of the free form of drugs in routine practice. Thus, the guidelines do not include pharmacodynamic targets for the free concentration, due to the lack of scientific data on the subject.
Detailed description
Since 2019, the Rouen University Hospital Pharmacology Laboratory has been measuring the non-protein-bound plasma concentrations of certain beta-lactam antibiotics. The analyzed sample comes from ultrafiltration of the plasma sample, a pre-analytical technique used in several studies on the free form of vancomycin. Access to this new technique at Rouen University Hospital gives us the opportunity to study free vancomycin concentrations in ICU patients.
This study therefore aims to investigate free vancomycin plasma concentrations in patients admitted to the ICU treated for suspected or proven Gram-positive cocci infection, and for whom a dosage has been prescribed as part of routine practice.
This prospective study aims to specifically analyze the concentration of the free form of vancomycin, but also to determine whether certain clinical or biological factors could predict this concentration. The long-term objective would be to be able to better individualize dosage regimens for vancomycin, a molecule with high inter-individual variability in intensive care patients, with the aim of reducing both underdoses, which are responsible for therapeutic failures, and overdoses, which are responsible for toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancomycin plasma dosage group | – | –Any intensive care patient at the Rouen University Hospital undergoing a plasma vancomycin dosage carried out as part of routine care for a suspected or proven Gram + Cocci infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns any intensive care patient at the Rouen University Hospital undergoing a plasma vancomycin dosage carried out as part of routine care for a suspected or proven Gram + cocci infection.
Key inclusion criteria (4 listed)
- Adult patient hospitalized in intensive care,
- Treated with vancomycin for a proven or suspected Gram-positive cocci infection,
- For whom a plasma vancomycin dose has been prescribed
- Patient who has been informed and has expressed verbal non-opposition. If the patient is unable to express their non-opposition (emergency situations), non-opposition must be obtained from the patient's representative, their trusted person, or, failing that, a relative.
Key exclusion criteria (6 listed)
- Objection from the patient or their relatives
- Discontinuous administration of vancomycin
- Total plasma vancomycin levels measured 5 days or more prior to inclusion, with the plasma sample being stored in the laboratory for only 5 days, as is standard practice.
- Individuals not covered by a social security scheme
- Failure to perform the prescribed vancomycin dosage: discontinuation of vancomycin, death, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of plasma concentration of the free form of vancomycin
Time frame: 24 hours after the start of continuous vancomycin infusion treatment
The primary endpoint is determined by the measurement of the plasma concentration of the free form of vancomycin during the total plasma concentration measurement after at least 24 hours of continuous infusion treatment.
5 secondary outcomes
Measurement of the fraction of the non-protein-bound form of vancomycin in plasma
Time frame: 24 hours
To determine the areas under the 24-hour curve (AUC24h) for total plasma protein-bound forms of vancomycin
Time frame: 24 hours
To compare the areas under the 24-hour curve (AUC24h) for total and non-plasma protein-bound forms of vancomycin
Time frame: 24 hours
To determine the areas under the 24-hour curve (AUC24h) for non-plasma protein-bound forms of vancomycin
Time frame: 24 hours
To assess the frequency of achieving vancomycin pharmacodynamic targets for its total plasma concentration
Time frame: 24 hours
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 29 Jun 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Philippe PG GOUIN, Professor study director
University Hospital, Rouen
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 Plasma Concentration, run by University Hospital, Rouen at 1 site in France.
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 6 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 29 Jun 2025. 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 France. 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?
Measurement of plasma concentration of the free form of vancomycin (time frame: 24 hours after the start of continuous vancomycin infusion 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 29 Jun 2025.