Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection

NCT02000414 | Completed DMC

• 1 other identifier: 2012-005699-33
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Infection

Keywords

intraperitoneal; peritoneal dialysis; daptomycin; pharmacokinetics; peritonitis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Primary endpoint : Pharmacokinetics study : Evaluation of : * the maximum plasma concentration, * areas under the curve * compartments clearances, * the time during which dialysate concentration is greater than 20mg /L (5xEnterococcus CMI)

  14 days

Secondary Outcomes (1)

• tolerance

  14 days

Study Arms (1)

intraperitoneal daptomycin

EXPERIMENTAL

3 first patients : 200mg/day 3 following patients : 300mg/day

Drug: intraperitoneal daptomycin

Interventions

intraperitoneal daptomycin DRUG

intraperitoneal daptomycin administartion and study of daptomycin kinetics

intraperitoneal daptomycin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years
• Hospitalized CAPD patients with Gram positive peritoneal infection : ISPD criterias
• Presence of two clinical signs and symptoms : abdominal pain, nausea, vomiting, diarrhea, fever and cloudy dialysate
• Peritoneal dialysate WBC\>100/µL with at least 50% polymorphonuclear neutrophil cells
• Demonstration of bacteria on Gram stain or culture
• on peritoneal dialysis for at least 3 months
• written consent, obtained from either the patient, one of his/her relatives, the trusted person who was designated beforehand or, if not possible, emergency enrollment.
• patient has a life expectancy greater than 6 months

You may not qualify if:

• Known allergy to daptomycin
• Peritoneal infection with Gram negative only
• Patient with CPK\>5UNL
• patients already treated with antibiotics, antifungals within 4 weeks prior to the event
• Patient with hepatic impairment
• Patient with arguments for an extra-peritoneal site of infection
• Patient with severe intercurrent illness (eg, hematologic malignancies, patients on chemotherapy)
• Infection by daptomycin-resistant germ
• HMGCoA reductase, fibrates or ciclosporin treatment
• Pregnant or breast-feeding women

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Néphrologie CHU de Caen

Caen, 14000, France

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Thierry Lobbedez, Pr

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

• Maxence FICHEUX, Dr

  University Hospital, Caen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: dose-finding study

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: December 4, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2017-01

Locations

FR (1)