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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02411331
• Date of registration: 03/04/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public 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 Etha-LOCK
• Scientific 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
• Date of first enrolment: March 2015
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02411331
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Patrick LACARIN

• Name: Olivier LESENS
• Affiliation: University Hospital, Clermont-Ferrand

• Name: Patrick LACARIN

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lock Solution

Catheter Related Blood Stream Infections

Intravenous Drug Delivery Systems

Central Venous Catheter Infection

Coagulase-negative Staphylococci Infection

Intervention(s)

Drug: Ethanol 40% + Enoxaparine 400UI/ml

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

Primary Outcome(s)

Favorable evolution without complication up to the end of implantable venous access port use [Time Frame: at 12 week]

Recovery at 12 week following the lock solution treatment completion [Time Frame: at 12 week]

Favorable evolution without complication until the implantable venous access port withdrawal [Time Frame: at 12 week]

Secondary Outcome(s)

Mortality due to infection of the port [Time Frame: at day 1]

Negative peripheral and port blood cultures [Time Frame: at day 3 and day 10]

Blood alcohol concentration [Time Frame: 30 min after the first lock solution treatment]

Side effects evaluation [Time Frame: at day 1]

Implantable venous access port withdrawal rate [Time Frame: at day 1]

Mechanical complication rate [Time Frame: at day 1]

Secondary ID(s)

CHU-0232

2014-A00488-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hôpital Nord (Saint-Etienne)

Centre Jean Perrin

Hôpital de la Croix-Rousse

University Hospital, Grenoble

Centre Leon Berard

CH Henri Mondor (Aurillac)

CH de Chambéry

CHG Jacques Lacarin (Vichy)