Peritoneal InfectionDAPTODPNCT02000414
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection
A study testing intraperitoneal daptomycin in people with Peritoneal Infection, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peritoneal Infection
- What is being tested?
- intraperitoneal daptomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection
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.
Read more
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.
Read the 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
- Being tested
- intraperitoneal daptomycin
- Keywords
- intraperitoneal, peritoneal dialysis, daptomycin, pharmacokinetics, peritonitis
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal daptomycinDrug
intraperitoneal daptomycin administartion and study of daptomycin kinetics
| Study group | Role | What they receive |
|---|---|---|
| intraperitoneal daptomycin | Experimental | 3 first patients : 200mg/day 3 following patients : 300mg/day Receives: Drug: intraperitoneal daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days
Secondary outcomes (1)
tolerance
CPK<5N
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- dose-finding study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lobbedez, Pr, Principal investigator, University Hospital, CaenMaxence FICHEUX, Dr, Study director, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000414
- Sponsor's protocol ID
- 2012-005699-33
- Acronym
- DAPTODP
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Patients With Peritoneal Dialysis and Peritoneal Infection
- ClinicalTrials.gov ID
- NCT02000414
- Acronym / sponsor ID
- DAPTODP / 2012-005699-33
- Conditions
- Peritoneal Infection
- Keywords
- intraperitoneal, peritoneal dialysis, daptomycin, pharmacokinetics, peritonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- dose-finding study
| Arm | Type | Receives |
|---|---|---|
| intraperitoneal daptomycin | Experimental | Drug: intraperitoneal daptomycin3 first patients : 200mg/day 3 following patients : 300mg/day |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraperitoneal daptomycinintraperitoneal daptomycin administartion and study of daptomycin kinetics | Drug | intraperitoneal daptomycin |
Primary outcome
Pharmacokinetics
Time frame: 14 days
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)
1 secondary outcome
tolerance
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Lobbedez, Pr principal investigator
University Hospital, Caen
Maxence FICHEUX, Dr study director
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraperitoneal daptomycin in people with Peritoneal Infection, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.