Etha-LOCK: 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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT02411331

Collaborator

Centre Jean Perrin (Other), Jacques Lacarin Hospital Center (Other), CH Henri Mondor (Aurillac) (Other), Hôpital Nord (Saint-Etienne) (Other), University Hospital, Grenoble (Other), CH de Chambéry (Other), Hôpital de la Croix-Rousse (Other), Centre Leon Berard (Other)

180

Enrollment

Location

Arms

22.1

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lock Solution Catheter Related Blood Stream Infections Central Venous Catheter Infection Intravenous Drug Delivery Systems Coagulase-negative Staphylococci Infection	Drug: Ethanol 40% + Enoxaparine 400UI/ml Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml	N/A

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Ethanol 40% + Enoxaparine 400UI/ml
Other: 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	Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml

Arm

Intervention/Treatment

Experimental: 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.

Drug: Ethanol 40% + Enoxaparine 400UI/ml

Other: 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

Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml

Outcome Measures

Primary Outcome Measures

Recovery at 12 week following the lock solution treatment completion [at 12 week]
Favorable evolution without complication up to the end of implantable venous access port use [at 12 week]
Favorable evolution without complication until the implantable venous access port withdrawal [at 12 week]

Secondary Outcome Measures

Negative peripheral and port blood cultures [at day 3 and day 10]
Mortality due to infection of the port [at day 1]
Implantable venous access port withdrawal rate [at day 1]
Mechanical complication rate [at day 1]
Blood alcohol concentration [30 min after the first lock solution treatment]
Side effects evaluation [at day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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