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

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre Jean Perrin; Centre Leon Berard; CH de Chambéry; CH Henri Mondor (Aurillac); CHG Jacques Lacarin (Vichy); Hôpital de la Croix-Rousse; Hôpital Nord (Saint-Etienne); Jacques Lacarin Hospital Center; University Hospital, Grenoble
• Treatments: Coagulase; Enoxaparin; Ethanol; Pharmaceutical Solutions; Vancomycin

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