NCT02411331

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

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

Interventions

Type	Name	Description
DRUG	Ethanol 40% + Enoxaparine 400UI/ml
DRUG	Vancomycine 5 mg/ml + Héparine 2500UI/ml

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-04-08
• Last updated: 2016-07-26

Locations

1 site across 1 country: France