PeritonitisNCT01101087
Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency
A study testing Taurolock in people with Peritonitis and Catheter-related Infections, run by Centre Hospitalier Universitaire de Nīmes at 15 sites in 2 countries.
Trial summary
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Catheter-related Infections, Renal Insufficiency
- What is being tested?
- Taurolock
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jul 2010to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Renal insufficiency, stage V (HAS 2007 classification)
- Requires incident peritoneal dialysis
- No signs of peritoneal infection on inclusion
- signed consent
- affiliated with a social security system
Who cannot join
- Patient will have a renal transplant in the upcoming year following dialysis
- Survival prognosis for one year is weak
- allergy to citrate, (cyclo)-taurolidine, or heparin
- patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
- patient has a thrombopenia caused by heparin
- impossible to inform the patient correctly
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- patient under guardianship
- patient already included in another biomedical research protocol
- no signed consent
- no social security system
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, 84902
CHU de Caen - Hôpital Clemenceau
Caen, 14033
CH de Chambéry
Chambéry, 73011
CH de Colmar - Hôpitaux Civils de Colmar
Colmar, 68024
Association CALYDIAL Vienne
Irigny, 69540
Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
La Roche-sur-Yon, 85925
AIDER - Clinque Jacques Mirouze
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, 75651
CH Pontoise - Centre Hospitalier René Dubos
Pontoise, 95300
Association AUB Santé Quimper
Quimper, 29000
Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
Saint-Pierre, 97448
CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
Valenciennes, 59322
ALTIR - Hôpital Brabois
Vandœuvre-lès-Nancy, 54504
French Polynesia1 site
Association APURAD
Paéa, 98711
About this study
Official title: Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.
- Being tested
- Taurolock, Placebo
- Keywords
- Dialysis
- Medical subject headings
- Peritonitis, Catheter-Related Infections, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockDevice
PlaceboOther
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
| Study group | Role | What they receive |
|---|---|---|
| Taurolock | Experimental | Not described Receives: Device: Taurolock |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of bacterial peritonitis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Branger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101087
- Sponsor's protocol ID
- PHRC-N/2009/BB
- Other IDs
- 2009-A00599-48
- Status last verified
- Dec 2015
- First submitted
- 8 Apr 2010
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacity of Taurolock in Preventing Primary Bacterial Peritonitis in Patients Undergoing Peritoneal Dialysis for Renal Insufficiency: a Randomized, Multicenter, Double Blind Study With Placebo
- ClinicalTrials.gov ID
- NCT01101087
- Acronym / sponsor ID
- PHRC-N/2009/BB
- Keywords
- Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Apr 2010 (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.
Dialysis catheters are sites of bacterial proliferation. The purpose of this study is to determine whether or not the use of Taurolock (a catheter lock solution) can prevent bacterial peritonitis in patients undergoing peritoneal dialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurolock | Experimental | Device: Taurolock |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Renal insufficiency, stage V (HAS 2007 classification)
- Requires incident peritoneal dialysis
- No signs of peritoneal infection on inclusion
- signed consent
Key exclusion criteria (10 listed)
- Patient will have a renal transplant in the upcoming year following dialysis
- Survival prognosis for one year is weak
- allergy to citrate, (cyclo)-taurolidine, or heparin
- patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
- patient has a thrombopenia caused by heparin
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 |
|---|---|---|
| Taurolock | Device | Taurolock |
| PlaceboInjectable sodium chloride conditioned in exactly the same manner as the experimental product. | Other | Placebo |
Primary outcome
Occurence of bacterial peritonitis
Time frame: 24 months
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 18 Dec 2015.
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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.
Bernard Branger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurolock in people with Peritonitis and Catheter-related Infections, run by Centre Hospitalier Universitaire de Nīmes at 15 sites in 2 countries.
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 6 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 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, French Polynesia. 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. Some participants in this study may receive a placebo. 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?
Occurence of bacterial peritonitis (time frame: 24 months). 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 18 Dec 2015.