Clinical trial NCT02411331: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lock Solution
Catheter Related Blood Stream Infections
Central Venous Catheter Infection
Intravenous Drug Delivery Systems
Coagulase-negative Staphylococci Infection
Keywords: Lock Solution
Catheter related blood stream infections
Central venous catheter infection
Intravenous Drug Delivery Systems
Coagulase-negative staphylococci infection
Ethanol lock solution
Vancomycin lock solution
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Centre Jean Perrin
name: Jacques Lacarin Hospital Center
name: CH Henri Mondor (Aurillac)
name: Hôpital Nord (Saint-Etienne)
name: University Hospital, Grenoble
name: CH de Chambéry
name: Hôpital de la Croix-Rousse
name: Centre Leon Berard
First posted: 2015-04-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Eligibility 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

Primary outcomes:
measure: Recovery at 12 week following the lock solution treatment completion
timeFrame: at 12 week
measure: Favorable evolution without complication up to the end of implantable venous access port use
timeFrame: at 12 week
measure: Favorable evolution without complication until the implantable venous access port withdrawal
timeFrame: at 12 week
Secondary outcomes:
measure: Negative peripheral and port blood cultures
timeFrame: at day 3 and day 10
measure: Mortality due to infection of the port
timeFrame: at day 1
measure: Implantable venous access port withdrawal rate
timeFrame: at day 1
measure: Mechanical complication rate
timeFrame: at day 1
measure: Blood alcohol concentration
timeFrame: 30 min after the first lock solution treatment
measure: Side effects evaluation
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Olivier LESENS
role: PRINCIPAL_INVESTIGATOR
References: