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

Catheter Related Blood Stream Infections Clinical Trial

— Etha-LOCK  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02411331
• Other study ID #: CHU-0232
• Secondary ID: 2014-A00488-39
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2015
• Last updated: July 25, 2016
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ethanol 40% + Enoxaparine 400UI/ml

• Vancomycine 5 mg/ml + Héparine 2500UI/ml

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	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), University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery at 12 week following the lock solution treatment completion		at 12 week	No
Primary	Favorable evolution without complication up to the end of implantable venous access port use		at 12 week	No
Primary	Favorable evolution without complication until the implantable venous access port withdrawal		at 12 week	No
Secondary	Negative peripheral and port blood cultures		at day 3 and day 10	No
Secondary	Mortality due to infection of the port		at day 1	No
Secondary	Implantable venous access port withdrawal rate		at day 1	No
Secondary	Mechanical complication rate		at day 1	No
Secondary	Blood alcohol concentration		30 min after the first lock solution treatment	No
Secondary	Side effects evaluation		at day 1	No