The trial is conducted on healthy male volunteers. An intravenous dose of 2 grams of dicloxacillin is administered intravenously and the muscle- and subcutaneous tissue concentrations are measured using Microdialysis. Plasma concentrations are also measured and the tissue concentration is compared to the plasma concentration to evaluate the tissue distribution of dicloxacillin. A small amount of dicloxacillin (0,25 g) is administered via the Microdialysis catheter as part of the investigation.
Conditions
Interventions
Trade Name: Diclocil®
Pharmaceutical Form: Infusion
INN or Proposed INN: DICLOXACILLIN
CAS Number: 3116-76-5
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 2,5-
Sponsors
Ortopædkirurgisk afdeling Odense Universitetshospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy male with no comorbidity - No allergies or intolerance to dicloxacillin or lidocaine - Age between 18 and 30 years - Ability to, and willingness to follow instructions during the trial - Informed, written consent, has been read, understood and signed 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: - Persons who do not speak or understand Danish - Persons with known acute or chronic illness - Persons who are currently using medication - Persons who are severely adipose - Persons who are current smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to investigate and validate a method for measuring the local concentration of antibiotics in muscle- and subcutaneous tissue, in human subjects. In addition we want to investigate the tissue distribution of dicloxacillin locally in muscle- and subcutaneous tissue, to evaluate whether or not the local tissue concentration, after a standard dose of 2 g of dicloxacillin, is sufficiently high to prevent infections of s. aureus and s. epidermidis. ;Secondary Objective: 1) Determine the in vitro and in vivo recovery of dicloxacillin when using the Microdialysis technique 2) Determine the reproducibility of the Microdialysis technique when measuring dicloxacillin concentrations 3) Compare the plasma and tissueconcentrations of dicloxacillin after intravenous administration 4) Compare dicloxacillin concentrations in muscle- and subcutaneous tissue 5) Investigate dicloxacillin concentration as a function of time after intravenous administration ;Primary end point(s): The primary end point is tissue concentrations of dicloxacillin in muscle- and subcutaneous tissue. The tissue concentrations are compared to the plasma concentration and a statistically significant difference is evaluated using students t-test at a significance level of 5 % In addition the tissue concentrations and plasma concentration are showed as a function of time. Time to peak concentration is measured and compared using the students t-test at a significance level of 5 % ;Timepoint(s) of evaluation of this end point: Samples of the microdialysis fluid are taken at intervals during the 9 hour trial period. At the same time points blood samples are drawn. All samples are cooled with dry ice during storage and are analyzed as soon as possible | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The measured tissue concentration of dicloxacillin is compared to the MIC values for s. aureus and s. epidermidis.;Timepoint(s) of evaluation of this end point: Same timepoints as for the primary endpoints. | — |
Countries
Denmark
Contacts
Public ContactOrthopedic research unit
Department of orthopedic surgery Odense university hospital
Outcome results
None listed