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 (Etha-LOCK)

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.

Study Overview

• Status: Unknown
• Conditions: Catheter Related Blood Stream Infections; Intravenous Drug Delivery Systems; Lock Solution; Central Venous Catheter Infection; Coagulase-negative Staphylococci Infection
• Intervention / Treatment: Drug: Ethanol 40% + Enoxaparine 400UI/ml; Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre Leon Berard; Centre Jean Perrin; University Hospital, Grenoble; Hôpital de la Croix-Rousse; Jacques Lacarin Hospital Center; CH Henri Mondor (Aurillac); Hôpital Nord (Saint-Etienne); CH de Chambéry

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 3, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Catheter related blood stream infections; Lock Solution; Central venous catheter infection; Intravenous Drug Delivery Systems; Coagulase-negative staphylococci infection; Ethanol lock solution; Vancomycin lock solution
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Sepsis; Infections; Communicable Diseases; Staphylococcal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Ethanol; Enoxaparin
• Other Study ID Numbers: CHU-0232; 2014-A00488-39 (Registry Identifier: 2014-A00488-39)