Orthopedic infections MedDRA version: 16.0 Level: LLT Classification code 10050155 Term: Knee prosthesis insertion System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Cefuroxim Fresenius Kabi
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: CEFUROXIME SODIUM
CAS Number: 56238-63-2
Concentration unit:
Sponsors
Orthopedic Research in Aarhus
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. - 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: - Allergy to cefuroxime og vancomycin - Ongoing treatment with cefuroxime - Female gender
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to asses the penetration of cefuroxime into bone tissue using the pharmacokinetic tool microdialysis. To dosing regimens are compared, traditional bolus infusion and continuous infusion. The primary endpoint is time above the MIC (minimal inhibitory concentration) for staphylococcus aureus. Secondary endpoints are standard pharmacokinetic parameters.;Secondary Objective: Not applicable;Primary end point(s): Time above the MIC (minimal inhibitory concentration) 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. AUC, Cmax);Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Denmark
Contacts
Public ContactMikkel Tøttrup
Orthopedic Research in Aarhus
Outcome results
None listed