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
Lock Solution · Catheter Related Blood Stream Infections · Central Venous Catheter Infection · Intravenous Drug Delivery Systems · Coagulase-negative Staphylococci Infection
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 63 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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)
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
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.
Drug: Ethanol 40% + Enoxaparine 400UI/ml
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
Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml
Ethanol 40% + Enoxaparine 400UI/ml DRUG
Not reported in this registry record.
Vancomycine 5 mg/ml + Héparine 2500UI/ml DRUG
Not reported in this registry record.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Recovery at 12 week following the lock solution treatment completion
Time frame: at 12 week
Not reported in this registry record.
Favorable evolution without complication up to the end of implantable venous access port use
Time frame: at 12 week
Not reported in this registry record.
Favorable evolution without complication until the implantable venous access port withdrawal
Time frame: at 12 week
Not reported in this registry record.
Secondary measures
Negative peripheral and port blood cultures
Time frame: at day 3 and day 10
Not reported in this registry record.
Mortality due to infection of the port
Time frame: at day 1
Not reported in this registry record.
Implantable venous access port withdrawal rate
Time frame: at day 1
Not reported in this registry record.
Mechanical complication rate
Time frame: at day 1
Not reported in this registry record.
Blood alcohol concentration
Time frame: 30 min after the first lock solution treatment
Not reported in this registry record.
Side effects evaluation
Time frame: at day 1
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
CHU Clermont-FerrandClermont-Ferrand, FranceStatus unknown
Study team and timeline
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Study start
- Apr 14, 2015 Actual
- Primary completion
- Apr 14, 2020 Actual
- Study completion
- Feb 4, 2021 Actual
- First posted
- Apr 8, 2015 Estimated
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study 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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026