NCT02000414

Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection

Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Peritoneal Infection

Interventions

Type	Name	Description
DRUG	intraperitoneal daptomycin	intraperitoneal daptomycin administartion and study of daptomycin kinetics

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-12-04
• Last updated: 2018-01-25

Locations

1 site across 1 country: France