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.

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)

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