drugset / Trial / NCT02000414

Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection

NCT02000414

Completed 8 enrolled University Hospital, Caen
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2013-09
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Daptomycin Other / unclassified 200 mg Other
Subject Daptomycin Other / unclassified 300 mg Other