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

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.

Conditions

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

Interventions

DRUG

Ethanol 40% + Enoxaparine 400UI/ml

DRUG

Vancomycine 5 mg/ml + Héparine 2500UI/ml

Sponsors & Collaborators

• Centre Jean Perrin

  collaborator OTHER

• Jacques Lacarin Hospital Center

  collaborator OTHER

• CH Henri Mondor (Aurillac)

  collaborator UNKNOWN

• Hôpital Nord (Saint-Etienne)

  collaborator UNKNOWN

• University Hospital, Grenoble

  collaborator OTHER

• CH de Chambéry

  collaborator UNKNOWN

• Hôpital de la Croix-Rousse

  collaborator OTHER

• Centre Leon Berard

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Olivier LESENS · University Hospital, Clermont-Ferrand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• France

Study Locations