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)

University Hospital, Clermont-Ferrand

Status: Unknown

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

Treatments: Drug: Vancomycine 5 mg/ml + Héparine 2500UI/ml; Drug: Ethanol 40% + Enoxaparine 400UI/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT02411331

2014-A00488-39 (Registry Identifier)

CHU-0232

Details and patient eligibility

About

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.

Full 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)

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Experimental group

Experimental group

Description:

90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.

Treatment:

Drug: Ethanol 40% + Enoxaparine 400UI/ml

control group

Other group

Description:

90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study

Treatment:

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