Subjects under general anaesthesia after a knee surgery get a microdialysis probe insertio into the operated knee and a probe insertion into the thigh on the contralateral side. After the operation 2 different antibiotics (linezolid and curocef) are administered intravenously. Aim of the study is to measure concentrations of cefuroxime and linezolid in the synovial fluid of the knee and to relate these concentrations to corresponding concentrations in plasma and muscle tissue.
Conditions
Interventions
Trade Name: Cefuroxim "Astro"
Product Name: Cefuroxim
Product Code: 1–22175
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CEFUROXIME SODIUM
CAS Number: 56238-63-2
Concentr
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Female or male, aged >18 years. •Elective knee arthroscopy. •Written informed consent. Therapeutic regimens will be not affected by procedures of the present study. The concomitant antimicrobial therapy with antibiotics other than linezolid and cefuroxime will be permitted throughout the study period. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Allergy or hypersensitivity against study drugs. •Treatment with cefuroxime or linezolid within the last week prior to the start of the study •Treatment with another investigational drug within 1 month prior to start of study medication •Any medication considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator •Impaired renal function (creatinine >1.5 mg/dl). •Impaired liver function. •Patients testing positive for HIV at the screening visit. •Pregnancy or lactation. •Hemodialysis or hemofiltration. •Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator •No written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measurement of concentrations of cefuroxime and linezolid in the synovial fluid of the knee;Secondary Objective: Secondary objective of the trial is the relatation between measured concentration in synovial fluid and corresponding concentrations in plasma and muscle tissue.;Primary end point(s): AUCsynovia / AUCplasma ratio;Timepoint(s) of evaluation of this end point: every 30minutes for a period of 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cmax, tmax, t1/2ß, Cmax / MIC, AUC / MIC, T > MIC.;Timepoint(s) of evaluation of this end point: every 30minutes for a period of 8 hours | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Outcome results
None listed