any patient with a BMI >= 30kg/m² and has a simple or severe infection. MedDRA version: 14.0 Level: PT Classification code 10060945 Term: Bacterial infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -patient >= 18y -any hospitalised obese patient (BMI >= 30kg/m²), receiving an intravenous broad spectrum B-lactam , for an infection (suspected or confirmed). 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: -hemodialysis or renal replacement therapy -pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determine the pharmacocinetic parameters of broad spectrum B-lactams administred at usual doses in obese patients in order to propose dosing regimens of antibiotics based on patient weight. ;Secondary Objective: ;Primary end point(s): | — |
Countries
Belgium
Contacts
Hopital Erasme