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

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. 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)

Eligibility criteria:
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

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