EUCTR2014-002973-13-FRActive, not recruitingPhase 1
Sampling Antibiotics in Renal Replacement Therapy: the AZUREA contribution - SMARRT
CHU de NIMES0 sites100 target enrollmentStarted: June 22, 2015Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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