Measurements of the antimicrobial vancomycin in subcutaneous tissue and bone tissue using microdialysis

Pharmacokinetics of vancomycin in cancellous and cortical bone obtained by microdialysis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000258-12-DK

Enrollment

Unknown

Registered

2014-08-12

Start date

2014-10-15

Completion date

Unknown

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic infections MedDRA version: 17.1 Level: LLT Classification code 10050155 Term: Knee prosthesis insertion System Organ Class: 100000004865

Interventions

Trade Name: Vancomycin "Hospira" Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: VANCOMYCIN CAS Number: 1404-90-6 Concentration unit: mg milligra

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - The patients must be scheduled for a knee prosthesis. The indication must be arthrosis -Normal kidney function. Serum creatinine must be within the range of 60 – 100 µmol/l. - Male gender - The patients must be competent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Allergy to cefuroxime og vancomycin - Ongoing treatment with vancomycin - Female gender

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is to asses the penetration of vancomycin into bone tissue using the pharmacokinetic tool microdialysis. The primary endpoint is the area under the concentration-time curve (AUC) above the MIC (minimal inhibitory concentration) for staphylococcus aureus. Secondary endpoints are standard pharmacokinetic parameters.;Secondary Objective: Not applicable;Primary end point(s): The ratio of area under the concentration-time curve (AUC) to minimal inhibitory concentration (MIC) = AUC:MIC, for staphylococcus aureaus;Timepoint(s) of evaluation of this end point: At the end of the study	—

Measure

Time frame

Main Objective: The objective of this trial is to asses the penetration of vancomycin into bone tissue using the pharmacokinetic tool microdialysis. The primary endpoint is the area under the concentration-time curve (AUC) above the MIC (minimal inhibitory concentration) for staphylococcus aureus. Secondary endpoints are standard pharmacokinetic parameters.;Secondary Objective: Not applicable;Primary end point(s): The ratio of area under the concentration-time curve (AUC) to minimal inhibitory concentration (MIC) = AUC:MIC, for staphylococcus aureaus;Timepoint(s) of evaluation of this end point: At the end of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax);Timepoint(s) of evaluation of this end point: At the end of the study	—

Countries

Denmark

Contacts

Public ContactMats Bue

Hospital Unit Horsens

matsbue6@rm.dk004525599294

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026