To Assess the Tissular and Plasma Kinetics of Ertapenem
Conditions
Brief summary
Goal of study: To assess the tissular and plasma kinetics of ertapenem; To determine the optimal dosages in the patients according to norepinephrine administration: * to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups with norepinephrine or without norepinephrine according to their hemodynamic status. * to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine. Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).
Interventions
DRUGErtapenem
1g a day by drip of 30 min
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and more * negative pregnancy test * HIV/HBV, HCV negative tests * Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
Exclusion criteria
* refractory septic shock requiring use of additional catecholamines * patients with positives tests for HIV, HBV, HCV * pregnant females * allergic insufficiency * hemodiafiltration * contraindication to microdialysis catheter set-up * severe arteritis of lower extremities * treatment with vasodilatators * prior history of aorto-iliac shunt * involvement in a clinical trial in the last three months * exclusion from national records * non affiliated to securité sociale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the tissular and plasma kinetics of ertapenem | 24 months |
Countries
France
Outcome results
None listed