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.

Brief 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

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

Brief Summary

Implantable venous access port infections are mainly due to coagulase negative staphylococci<br /> and may be managed by antibiotic lock therapy with retention of the port. Most of the time a<br /> vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in<br /> eradicating the staphylococcal biofilm in the port. Another disadvantage of<br /> Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of<br /> catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does<br /> 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)