Plasma Concentrations of the Non-protein-bound Form of Vancomycin

NCT07043673 | Completed

• 2 other identifiers: 2022/058/OBN° IDRCB : 2022-A00706-37
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Plasma Concentration

Keywords

vancomycine

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  24 hours

• To determine the areas under the 24-hour curve (AUC24h) for total plasma protein-bound forms of vancomycin

  24 hours

• To compare the areas under the 24-hour curve (AUC24h) for total and non-plasma protein-bound forms of vancomycin

  24 hours

• To determine the areas under the 24-hour curve (AUC24h) for non-plasma protein-bound forms of vancomycin

  24 hours

• To assess the frequency of achieving vancomycin pharmacodynamic targets for its total plasma concentration

  24 hours

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Objection from the patient or their relatives
• Discontinuous administration of vancomycin
• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood from samples taken as part of routine care

Study Officials

• Philippe PG GOUIN, Professor

  University Hospital, Rouen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: June 17, 2022
• Primary Completion: August 31, 2024
• Study Completion: March 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)