sepsis or septic shock MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: amikacin
Pharmaceutical Form: Powder for injection
INN or Proposed INN: AMIKACIN
CAS Number: 37517-28-5
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient, male or female, over the age of 18, hospitalized in the critical care unit of the Lyon-Sud Hospital Center. - Patient presenting a clinical picture of sepsis or severe sepsis defined by the latest international recommendations. - Patient to be treated with amikacin + piperacillin / tazobactam. - Patient affiliated to a social security scheme, - having agreed to participate in the study 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Minor patient. - Patient participating in another research potentially interfering (investigator's judgment) with the results of this study. - Refusal of the patient to participate in the study. - Major patient protected under the terms of the law (Public Health Code). - Patient with a known history of hypersensitivity or contraindication to amikacin, piperacillin or tazobactam. - Patient known to have previously received piperacillin / tazobactam or amikacin prior to inclusion of the patient. - Patient treated at the time of inclusion by extra-renal cleansing techniques.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measure the association between the pharmacokinetics parameters of piperacillin, tazobactam (plasma clearance and volume of distribution) and those of amikacine in patients treated by the association for septic symdrome in Intensive care unit.;Secondary Objective: - Elaboration of population pharmacokinetics models of piperacillin, tazobactam, permitting the estimation of pharmacokinetics parameters of these molecules in this population. - Evaluation of the influence of covariates other than those relating to the pharmacokinetic of amikacin on the pharmacokinetic parameters of piperacillin and tazobactam. ;Primary end point(s): -Patient mineur. -Patient participant à une autre recherche pouvant interférer (jugement de l’investigateur) avec les résultats de la présente étude. -Refus du patient de participer à l’étude. -Patient majeur protégé selon les termes de la loi (Code de la santé Publique). -Patient ayant des antécédents connus d’hypersensibilité ou de contre-indication à l’amikacine, la pipéracilline ou au tazobactam. -Patient connu comme ayant déjà reçu l’association pipéracilline/tazobactam ou de l’amikacine avant l’inclusion du patient. -Patient traité au moment de l’inclusion par des techniques d’épuration extra-rénale. ;Timepoint(s) of evaluation of this end point: H0 (Baseline), H1 (1 hour after the beginning of the amikacin perfusion), H5, H7, H24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Objective function of the pharmacokinetic models tested (likelihood ratio test). - Value of correlation coefficient ß binding a covariate to a pharmacokinetic parameter (Wald test);Timepoint(s) of evaluation of this end point: H0 (Baseline), H1 (1 hour after the beginning of the amikacin perfusion), H5, H7, H24 | — |
Countries
France
Contacts
Public ContactElisa Letellier
Hospices Civils de Lyon
Outcome results
None listed