aviolle FLUO-POP

Conditions: pharmacokinetics of fluoroquinolones
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-004193-41-FR

Lead Sponsor: CHU de Rennes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- Pregnant woman
- Person major subject to legal protection, person deprived of liberty

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Collection of demographic, biological and clinical data<br>- 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