CancerNCT02255318
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
A study testing Taurolock in people with Cancer and Infection, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Taurolock
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2015to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over
- Patients with solid cancer
- Patients with implantable catheter
- Patients receiving parenteral nutrition
- Patient affiliated to a social security scheme or beneficiary of such a regime
Who cannot join
- Patients refusing to participate in the protocol
- Patients already receiving preventive lock of IRCIC
- Known citrate or (cyclo) allergy -taurolidine
- Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.
- Participation in another protocol for the prevention of infections associated with central venous catheters
- Patients who did not sign the consent
- Patient with a status of socio-legal protection
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Edouard Herriot
France, Lyon, 69003
Julien Forestier, julien.forestier@chu-lyon.fr
- Recruiting
Hôpital de la Croix Rousse
France
Marielle GUILLET, marielle.guillet@chu-lyon.fr
- Recruiting
Groupement Hospitalier Lyon Sud
Pierre-Bénite
Marion Chauvenet, marion.chauvenet@chu-lyon.fr
About this study
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.
This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.
- Being tested
- Taurolock, Placebo
- Keywords
- Taurolock®, infections related to chambers implantable catheter, patients with cancer receiving parenteral nutrition
- Medical subject headings
- Neoplasms, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockDevice
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Taurolock | Experimental | Patients received Taurolock lock for 3 months administration. Receives: Device: Taurolock |
| Placebo | Placebo comparator | Patients received placebo lock (physiological serum) for 3 months administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.
Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.
Measured: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
Secondary outcomes (2)
Delay onset of IRCIC
Measured: between the inclusion and 3 months after the beginning of the study
Duration of hospitalizations for IRCIC.
Measured: between the inclusion and 3 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile CHAMBRIER, PH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255318
- Sponsor's protocol ID
- 2013-792
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT02255318
- Acronym / sponsor ID
- 2013-792
- Keywords
- Taurolock®, infections related to chambers implantable catheter, patients with cancer receiving parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Oct 2014 (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.
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.
This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurolock | Experimental | Device: TaurolockPatients received Taurolock lock for 3 months administration. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received placebo lock (physiological serum) for 3 months administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years and over
- Patients with solid cancer
- Patients with implantable catheter
- Patients receiving parenteral nutrition
- Patient affiliated to a social security scheme or beneficiary of such a regime
Key exclusion criteria (7 listed)
- Patients refusing to participate in the protocol
- Patients already receiving preventive lock of IRCIC
- Known citrate or (cyclo) allergy -taurolidine
- Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.
- Participation in another protocol for the prevention of infections associated with central venous catheters
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 |
| Placebo | Drug | Placebo |
Primary outcome
The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.
Time frame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.
Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.
2 secondary outcomes
Delay onset of IRCIC
Time frame: between the inclusion and 3 months after the beginning of the study
Duration of hospitalizations for IRCIC.
Time frame: between the inclusion and 3 months after the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Cécile CHAMBRIER, PH principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurolock in people with Cancer and Infection, run by Hospices Civils de Lyon at 3 sites 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile CHAMBRIER, PH (4.72 00 15 25 ext. +33, cecile.chambrier@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush. (time frame: The incidence will be assessed between the inclusion and 3 months after the beginning of the study.). 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 28 Oct 2016.