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Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection (DAPTODP)

Primary Purpose

Peritoneal Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intraperitoneal daptomycin
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Infection focused on measuring intraperitoneal, peritoneal dialysis, daptomycin, pharmacokinetics, peritonitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Néphrologie CHU de Caen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intraperitoneal daptomycin

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

tolerance
CPK<5N

Full Information

First Posted
September 3, 2013
Last Updated
January 24, 2018
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02000414
Brief Title
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection
Acronym
DAPTODP
Official Title
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Infection
Keywords
intraperitoneal, peritoneal dialysis, daptomycin, pharmacokinetics, peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
dose-finding study
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraperitoneal daptomycin
Arm Type
Experimental
Arm Description
3 first patients : 200mg/day 3 following patients : 300mg/day
Intervention Type
Drug
Intervention Name(s)
intraperitoneal daptomycin
Intervention Description
intraperitoneal daptomycin administartion and study of daptomycin kinetics
Primary Outcome Measure Information:
Title
Pharmacokinetics
Description
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)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
tolerance
Description
CPK<5N
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Lobbedez, Pr
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maxence FICHEUX, Dr
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
Néphrologie CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection

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