Infections During Organ Replacement Therapy
Conditions
Keywords
pharmacokinetics, doripenem, renal replacement therapy, MARS, organ replacement therapy
Brief summary
The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.
Interventions
OTHERPharmacokinetic profiling
Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Suspected or proven bacterial infection requiring parenteral antibiotic therapy. * Organ replacement therapy (MARS, CVVHDF or HD)
Exclusion criteria
* Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. * An expected survival of less than two days. * Known pregnancy * Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study * Doripenem as monotherapy for resistent species or fungal infections. * Other reasons opposing the study participation on the discretion of the investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of organ replacement therapy on area under curve of doripenem serum concentration | day 15 | Pharmacokinetic samples are drawn from each patient during the trial. Analysis by HPLC will be conducted after the end of the trial. |
Countries
Austria
Outcome results
None listed