pharmacokinetics of fluoroquinolones
Conditions
Interventions
Trade Name: ciprofloxacine
Product Name: ciprofloxacine
Pharmaceutical Form: Solution for infusion
Trade Name: ofloxacine
Product Name: ofloxacine
Pharmaceutical Form: Tablet
Sponsors
CHU de Rennes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age> 18 years - Medical Intensive Care : Infection treated with ciprofloxacin IV - Orthopedics: staph infection treated with oral ofloxacin - Free and informed consent in writing 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant woman - Person major subject to legal protection, person deprived of liberty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Measurement of plasma concentrations of ciprofloxacine and ofloxacine between two administrations (8-10 samples per patient) on the 4th day of treatment initiated by the usual criteria for management of the disease;Timepoint(s) of evaluation of this end point: the 4th day of treatment initiated;Main Objective: model the pharmacokinetics of fluoroquinolones by a analysis of population ;Secondary Objective: - define a limited sampling scheme allowing the estimation of area under the curve concentrations of the antibiotic - determine the pharmacokinetic-pharmacodynamic index in specific subpopulations (ICU patients, patients treated for bone and joint infection) or bacteria for which the index is unknown (including staphylococci) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Collection of demographic, biological and clinical data - Comparison of pharmacokinetic parameters calculated or estimated (area under the concentration curve, maximum concentration) to the minimum inhibitory concentration (real or modal) fluoroquinolone interest in the bacteria treated;Timepoint(s) of evaluation of this end point: the 4th day of treatment initiated | — |
Countries
France
Contacts
Public ContactGanivet
CHU de Rennes
Outcome results
None listed