Multiple-dose Pharmacokinetics of Doripenem during continuous venovenous hemodiafiltration and molecular adsorbent recirculating system in ICU patients and during hemodialysis in longterm hemodialysis patients.
- Conditions
- 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.
- Registration Number
- EUCTR2009-018010-18-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik f.Innere Medizin I,Abt. f. Infektionen u.Tropenmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method