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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Lock Solution, Catheter Related Blood Stream Infections, Central Venous Catheter Infection, Intravenous Drug Delivery Systems, Coagulase-negative Staphylococci Infection

Intervention / Treatment
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* Drug: Ethanol 40% + Enoxaparine 400UI/ml
* Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br> <br> |
| Other: control group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery at 12 week following the lock solution treatment completion |  | at 12 week | 
| Favorable evolution without complication up to the end of implantable venous access port use |  | at 12 week | 
| Favorable evolution without complication until the implantable venous access port withdrawal |  | at 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative peripheral and port blood cultures |  | at day 3 and day 10 | 
| Mortality due to infection of the port |  | at day 1 | 
| Implantable venous access port withdrawal rate |  | at day 1 | 
| Mechanical complication rate |  | at day 1 | 
| Blood alcohol concentration |  | 30 min after the first lock solution treatment | 
| Side effects evaluation |  | at day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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