Peritoneal Infection Clinical Trial
— DAPTODPOfficial title:
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection
| Verified date | January 2017 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Néphrologie CHU de Caen | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | tolerance | CPK<5N | 14 days |