Pharmacokinetics of ertapenem in a three-weekly dosing regime in patients with end stage renal disease depending on hemodialysis

Imipinem-Cilastine (Tienam) is used in the threatment of carbapenem susceptible
infections in patients with end-stadium-renal-disease depending on
hemodialysis. Of the carbapenems only Imipinem-Cilastine is approved in
patients depending on hemodialysis. A disadvantage is the twice daily
intravenous injection for which hospitalization is necassary.
Ertapenem (Invanz) is not approved in patients depending on hemodialysis. Based
on one pharmacokinetic study a dose reduction of 50% is recommended. Our
hypothesis is that an interval increase instead of a dose reduction will also
give effective druglevels. In the current daily pratice Ertapenem is already
administered three times a week after a hemodialysissession. In this
dosageregime no hospitaladmission is needed. In this study we will investigate
this dosageregime and descripe the pharmacokinetics in hemodialysis patients.

To investigate the Ertapenem plasmaconcentration time curves in a dosingscheme
of three administrations per week after hemodialysis in patients with end stage
renal disease depending on hemodialysis. To find a pharmacokinetic model to
describe plasma concentration time curves for Ertapenem?

Single center, multiple-dose, pharmacokinetic study

Threatment of the infection with Ertapenem.

The risks are minimal. In the current clinical practice patients are treated
with this dosageregime of three administration a week after hemodialysis. With
this research we try to descripe this regime with a pharmacokinetic model.
The burden is limited. 6 bloodsamples will be collected, for only 2 samples
venapunction is needed. Patients have to stay 30 minutes (administration
ertapenem) + 10 minutes (to collect bloodsample) extra in the hospital. A
hospitalisation is prevented using this dosageregime.