pharmacokinetics of Doripenem during CVVHDF(intensive care patients continuous venovenous haemodiafiltration), MARS(extracorporeal liver assist device, using a hollow fiber dialysis column in which blood of the patient is dialyzed across an albumin coated membrane, while at the same time maintaining a constant flow of albumin rich dialysate in the extracapillaray compartment) and intermittent hemodialysis.
Conditions
Interventions
Trade Name: DORIBAX 500 mg - Pulver zur Herstellung einer Infusionsloesung
Product Name: DORIBAX 500 mg - Pulver zur Herstellung einer Infusionsloesung
Pharmaceutical Form: Powder and solvent for solu
Sponsors
Medizinische Universität Wien, Univ.Klinik f.Innere Medizin I,Abt. f. Infektionen u.Tropenmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age >18 years b) Suspected or proven bacterial infection requiring parenteral antibiotic therapy. c) Organ replacement therapy (MARS, CVVHDF or HD) 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
Exclusion criteria: a) Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. b) An expected survival of less than two days. c) Known pregnancy d) Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study e) Doripenem as monotherapy for resistent species or fungal infections. f) Other reasons oposing the study participation on the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -pharmacokinetics of Doripenem during CVVHDF, MARS and intermittent hemodialysis;Secondary Objective: -;Primary end point(s): The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction. | — |
Countries
Austria
Outcome results
None listed