optimization of doses of broad spectrum B-lactames (ceftazidim and meropenem) and vancomycin in septic patient traeted with chronic hemodialysis.

Conditions: hemodialysisoligoanuriasepsis
MedDRA version: 14.0Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0Level: LLTClassification code 10066622Term: Chronic hemodialysisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-001573-10-BE

Lead Sponsor: Hôpital Erasme

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

-patient with a chronic renal failure and aligo-anuric in hemodialysis, hospitalised or not.
-intravenous antibiotics traet gived to treat an infection.
-patient receiving a combination of ceftazidim/vancomicyn or meropenem/vancomycin may be included.
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) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-severe sepsis and sepsis shock
-doses higher than recommanded antibiotics (traetment of meningitis...)
-pregnant woman
-age < 18y
-antibiotics prophylaxis
-obese (BMI > 30 kg/m²) or cachexic (BMI < 15 kg/m²) patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: interventional study of the pharmacocinetics of ceftazidim, meropenem and vancomycin in chronic hemodialysis patients tank to establish recommandations for doses of this antibiotics based on the evidence. ;Secondary Objective: ;Primary end point(s): define the pharmacokinetics of antibiotics examined in this study in patient treated with chronic hemodialysis.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): adjust the schedule of administration of antibiotics (B-lactams and vancomycin) for patient treated with chronic hemodialysis.