Peritoneal Infection Clinical Trial
Official title:
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection
Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In
France, It contributes to the technique failure, responsible for about 20% of cases of
transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to
studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.
Based on the recommendations of the International Society for Peritoneal Dialysis, the
intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics
(intravenous and intraperitoneal) was studied and protocols for IP administration were
validated.
Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is
presented as an alternative to vancomycin in infections resistant pathogens. The stability of
daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial activity as
well.
Seven patients were treated with daptomycin intraperitoneally successfully. But no study has
reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study
of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive
peritoneal infection.
Methodology:
Prospective, open-label, non-randomized pharmacokinetic study. Daptomycin will be given IP in
the CAPD fluid (200mg in 2L Nutrineal) once daily, in a 6 hours-dwell time. The process of
dialysis is done four times per day : three during the day (6,6,and 4 h) and one time at
night (8h). Duration of treatment depends on bacteria identified (14 or 21 days).
Analyses will be performed on data from all patients meeting the criteria for inclusion and
exclusion.
For each patient, plasma, dialysate and urine kinetics will be studied.
For each parameter, mean and standard deviation are calculated.
Number of centers & patients:
One center, twelve patients.
Sample size justification:
This is an observational pharmacokinetic study of consecutive PD patients presenting to Caen
University Hospital with peritoneal infection and who meet inclusion criterias over one year.
Population: CAPD patients with a Gram positive peritoneal infection
;