SepsisNutrilockNCT00545831
Effect of Taurolidin on Prevention of Bloodstream Infection
A study testing Taurolidine and Physiologic Serum in people with Sepsis, run by University Hospital, Rouen at 7 sites in France.
Trial summary
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Taurolidine and Physiologic Serum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 7 sitesFrance
- Study dates
- Oct 2007to Dec 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age superior to 18 years
- Home parenteral nutrition on tunnelized central venous catheters
- Bloodstream infection confirmed by differential hemocultures
- Informed consent form signed
- Negative B-HCG test
Who cannot join
- Subject unable to give his informed consent
- Pregnancy
- Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
- Hospital related infection
- Central venous catheters placed since less than 15 days
- Neutropenia < 500 PNN/mm3
Show all 11Show fewer
- Fungal Infection, polymicrobial who need ablation of the central venous catheters
- No-response to clinical treatment of the Infection
- Septic thrombophlebitis
- Chemotherapy ongoing
- On going malignancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
APHP Beaujon Hospital
Clichy
UH of Grenoble
Grenoble
UH of Lille
Lille
UH of Lyon
Lyon
UH of Nice
Nice
University Hospital of Rouen
Rouen, 76000
UH of Toulouse
Toulouse
About this study
Official title: Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.
The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.
Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.
- Conditions
- Sepsis
- Being tested
- Taurolidine, Physiologic Serum
- Keywords
- Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolidineDevice
2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
Physiologic SerumDevice
2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Use of taurolidine in prevention of bloodstream infection related to central venous access Receives: Device: Taurolidine |
| B | Placebo comparator | Use of Physiologic Serum to compare to arm A Receives: Device: Physiologic Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrence of catheter-related infection in each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2011
- Study completionDec 2011
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Lecleire, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545831
- Sponsor's protocol ID
- 2006/100/HP
- Other IDs
- 2007-A00618-45
- Acronym
- Nutrilock
- Status last verified
- Mar 2013
- First submitted
- 16 Oct 2007
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home
- ClinicalTrials.gov ID
- NCT00545831
- Acronym / sponsor ID
- Nutrilock / 2006/100/HP
- Conditions
- Sepsis
- Keywords
- Home Parenteral Nutrition, Sepsis Prevention, Central Venous Catheters, Taurolidine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Oct 2007 (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.
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.
The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.
Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: TaurolidineUse of taurolidine in prevention of bloodstream infection related to central venous access |
| B | Placebo comparator | Device: Physiologic SerumUse of Physiologic Serum to compare to arm A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age superior to 18 years
- Home parenteral nutrition on tunnelized central venous catheters
- Bloodstream infection confirmed by differential hemocultures
- Informed consent form signed
- Negative B-HCG test
Key exclusion criteria (11 listed)
- Subject unable to give his informed consent
- Pregnancy
- Subject who have a two or three-way catheter, or a non-tunnelized central venous catheter
- Hospital related infection
- Central venous catheters placed since less than 15 days
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 |
|---|---|---|
| Taurolidine2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months | Device | A |
| Physiologic Serum2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months | Device | B |
Primary outcome
Number of recurrence of catheter-related infection in each group
Time frame: 6 months
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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.
Stéphane Lecleire, MD principal investigator
University Hospital, Rouen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taurolidine and Physiologic Serum in people with Sepsis, run by University Hospital, Rouen at 7 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 11 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: stopped early, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Number of recurrence of catheter-related infection in each group (time frame: 6 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 5 Mar 2013.