Sampling Antibiotics in Renal Replacement Therapy: the AZUREA contributio

Phase 1

• Conditions: The study population concerns patients in participating Intensive care unit simultaneously requiring Renal Replacement Therapy and intravenous antibiotic therapy (Piperacillin-Tazobactam, Meropenem or Vancomycin).; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-002973-13-FR
• Lead Sponsor: CHU de NIMES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-22
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•The patient (or his/her authorized representative) has been correctly informed
•The patient (or his/her authorized representative) must have given his/her informed and signed consent.
•The patient must be insured or beneficiary of a health insurance plan.
•The patient is at least 18 years old.
•AKI requiring RRT (defined according to RIFLE, AKIN or KDIGO criteria41)
•Clinical indication for IV Piperacillin – Tazobactam, Meropenem or Vancomycin
•Expected do be on filter for at least 4 days
•Presence of intra-arterial line for blood sampling if RRT filter port sampling not possible

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•The patient is participating in another study that my interfere with the results or conclusions of this study
•Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
•The patient is in an exclusion period determined by a previous study
•The patient is under judicial protection
•The patient is an adult under guardianship
•The patient (or his/her authorized representative) refuses to sign the consent
•It is impossible to correctly inform the patient (or his/her authorized representative)
•The patient is pregnant, parturient or breastfeeding
•Imminent death / not expected to survive, etc.
•Major bleeding or Hb< 70 g/L or platelets < 20.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified