Lock SolutionEtha-LOCKNCT02411331
Randomized, Multicenter, Double-blind, Vancomycin-controlled Study to Evaluate the Efficacy of Ethanol Lock Solution for the Curative Treatment of Implantable Venous Access Port Infection Due to Coagulase-negative Staphylococci
A study testing Ethanol 40% + Enoxaparine 400UI/ml and Vancomycine 5 mg/ml + Héparine 2500UI/ml in people with Lock Solution and Catheter Related Blood Stream Infections, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lock Solution, Catheter Related Blood Stream Infections, Central Venous Catheter Infection
- What is being tested?
- Ethanol 40% + Enoxaparine 400UI/ml and Vancomycine 5 mg/ml + Héparine 2500UI/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jan 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
- Man or woman from 18 years old
- With probable or definite implantable venous access port infection
- With or without bacteraemia
- Infection due to coagulase-negative staphylococci (except for lugdunensis Staphylococci)
- Blood culture results available within 48 hours before inclusion
- With health insurance
Who cannot join
- Pregnant or breastfeeding woman
- Allergy to ethanol
- Patient with prosthetic cardiac valve
- Necessity of venous access port withdrawal
- Prior infection on the same venous access port
- Patients under supervision or (legal) guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Olivier LESENS
About this study
Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.
Read the detailed description
Type of study: multi-center, randomized, double-blind, parallel-group, controlled clinical trial.
Number of centers: 9 French centers in Auvergne and Rhône-Alpes regions
Medical product Ethanol 40% + Enoxaparine 400UI/ml Versus Vancomycin 5 mg/ml + Héparine 2500UI/ml
Patients
Patients eligible for inclusion will be randomized to one of the two groups:
- Experimental group: 90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.
- Control group: 90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study.
- For each group, in case of bacteraemia, the lock therapy is associated with a systemic antibiotic therapy using another venous line and optimized by a specialist in infectious diseases.
Study Performance
Patients will be assessed at baseline D0, 3 days (D3), 10 days (D10), 14 weeks (W14) after D0 as follows:
Visit 1 (D0 - baseline):
- Signature of an informed consent form.
- Demographic and clinical characteristics (sex, age, disease associated with implantable venous access port, implantable venous access port infection data, bacteraemia data)
Days 1 to 10
- Injection of ethanol or vancomycin lock solution in implantable venous access port
- Ethanolemia 30 minutes after injection, on first day
- Side effects evaluation
Visit 2 (D3) and Visit 3 (D10)
- Side effects evaluation
- Blood culture
- Bacteraemia data (antibiotic therapy modification)
Phone contact each week from week 2 to week 13
End Visit (W14)
- Side effects evaluation
- Blood culture
- Bacteraemia data (antibiotic therapy modification)
- Conditions
- Lock Solution, Catheter Related Blood Stream Infections, Central Venous Catheter Infection, Intravenous Drug Delivery Systems, Coagulase-negative Staphylococci Infection
- Being tested
- Ethanol 40% + Enoxaparine 400UI/ml, Vancomycine 5 mg/ml + Héparine 2500UI/ml
- Keywords
- Lock Solution, Catheter related blood stream infections, Central venous catheter infection, Intravenous Drug Delivery Systems, Coagulase-negative staphylococci infection, Ethanol lock solution, Vancomycin lock solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol 40% + Enoxaparine 400UI/mlDrug
Vancomycine 5 mg/ml + Héparine 2500UI/mlDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study. Receives: Drug: Ethanol 40% + Enoxaparine 400UI/ml |
| control group | Other | 90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study Receives: Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery at 12 week following the lock solution treatment completion
Measured: at 12 week
Favorable evolution without complication up to the end of implantable venous access port use
Measured: at 12 week
Favorable evolution without complication until the implantable venous access port withdrawal
Measured: at 12 week
Secondary outcomes (6)
Negative peripheral and port blood cultures
Measured: at day 3 and day 10
Mortality due to infection of the port
Measured: at day 1
Implantable venous access port withdrawal rate
Measured: at day 1
Mechanical complication rate
Measured: at day 1
Blood alcohol concentration
Measured: 30 min after the first lock solution treatment
Side effects evaluation
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lock SolutionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Jean Perrin, Jacques Lacarin Hospital Center, CH Henri Mondor (Aurillac), Hôpital Nord (Saint-Etienne), University Hospital, Grenoble, CH de Chambéry, Hôpital de la Croix-Rousse, Centre Leon Berard
- Responsible party
- Sponsor
- Investigators
- Olivier LESENS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411331
- Sponsor's protocol ID
- CHU-0232
- Other IDs
- 2014-A00488-39
- Acronym
- Etha-LOCK
- Status last verified
- Jul 2016
- First submitted
- 3 Apr 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double-blind, Vancomycin-controlled Study to Evaluate the Efficacy of Ethanol Lock Solution for the Curative Treatment of Implantable Venous Access Port Infection Due to Coagulase-negative Staphylococci
- ClinicalTrials.gov ID
- NCT02411331
- Acronym / sponsor ID
- Etha-LOCK / CHU-0232
- Conditions
- Lock Solution, Catheter Related Blood Stream Infections, Central Venous Catheter Infection, Intravenous Drug Delivery Systems, Coagulase-negative Staphylococci Infection
- Keywords
- Lock Solution, Catheter related blood stream infections, Central venous catheter infection, Intravenous Drug Delivery Systems, Coagulase-negative staphylococci infection, Ethanol lock solution, Vancomycin lock solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre Jean Perrin, Jacques Lacarin Hospital Center, CH Henri Mondor (Aurillac), Hôpital Nord (Saint-Etienne), University Hospital, Grenoble, CH de Chambéry, Hôpital de la Croix-Rousse, Centre Leon Berard
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Apr 2015 (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.
Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.
Detailed description
Type of study: multi-center, randomized, double-blind, parallel-group, controlled clinical trial.
Number of centers: 9 French centers in Auvergne and Rhône-Alpes regions
Medical product Ethanol 40% + Enoxaparine 400UI/ml Versus Vancomycin 5 mg/ml + Héparine 2500UI/ml
Patients
Patients eligible for inclusion will be randomized to one of the two groups:
- Experimental group: 90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.
- Control group: 90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study.
- For each group, in case of bacteraemia, the lock therapy is associated with a systemic antibiotic therapy using another venous line and optimized by a specialist in infectious diseases.
Study Performance
Patients will be assessed at baseline D0, 3 days (D3), 10 days (D10), 14 weeks (W14) after D0 as follows:
Visit 1 (D0 - baseline):
- Signature of an informed consent form.
- Demographic and clinical characteristics (sex, age, disease associated with implantable venous access port, implantable venous access port infection data, bacteraemia data)
Days 1 to 10
- Injection of ethanol or vancomycin lock solution in implantable venous access port
- Ethanolemia 30 minutes after injection, on first day
- Side effects evaluation
Visit 2 (D3) and Visit 3 (D10)
- Side effects evaluation
- Blood culture
- Bacteraemia data (antibiotic therapy modification)
Phone contact each week from week 2 to week 13
End Visit (W14)
- Side effects evaluation
- Blood culture
- Bacteraemia data (antibiotic therapy modification)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Ethanol 40% + Enoxaparine 400UI/ml90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study. |
| control group | Other | Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Man or woman from 18 years old
- With probable or definite implantable venous access port infection
- With or without bacteraemia
- Infection due to coagulase-negative staphylococci (except for lugdunensis Staphylococci)
- Blood culture results available within 48 hours before inclusion
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman
- Allergy to ethanol
- Patient with prosthetic cardiac valve
- Necessity of venous access port withdrawal
- Prior infection on the same venous access port
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 |
|---|---|---|
| Ethanol 40% + Enoxaparine 400UI/ml | Drug | Experimental group |
| Vancomycine 5 mg/ml + Héparine 2500UI/ml | Drug | control group |
Primary outcome
Recovery at 12 week following the lock solution treatment completion
Time frame: at 12 week
Favorable evolution without complication up to the end of implantable venous access port use
Time frame: at 12 week
Favorable evolution without complication until the implantable venous access port withdrawal
Time frame: at 12 week
6 secondary outcomes
Negative peripheral and port blood cultures
Time frame: at day 3 and day 10
Mortality due to infection of the port
Time frame: at day 1
Implantable venous access port withdrawal rate
Time frame: at day 1
Mechanical complication rate
Time frame: at day 1
Blood alcohol concentration
Time frame: 30 min after the first lock solution treatment
Side effects evaluation
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Related trials for Lock Solution
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Not yet recruitingObservational study
Survey of Practices Regarding the Use of Taurolidine Lock Solutions in Patients With Insertion of a Peripherally Inserted Central Catheter (PICC) in a Vascular Access Unit
Taurolidine Lock Solution
RecruitingPhase 3
Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients
Tunnelled Hemodialysis Catheter Infection
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.
Olivier LESENS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanol 40% + Enoxaparine 400UI/ml and Vancomycine 5 mg/ml + Héparine 2500UI/ml in people with Lock Solution and Catheter Related Blood Stream Infections, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 6 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 26 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery at 12 week following the lock solution treatment completion (time frame: at 12 week). The study lists 3 primary outcomes in all. 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 26 Jul 2016.