Trial | NCT02411331  Report issue

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    180
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.
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 Started
Mar 31
2015
Primary Completion
Jan 31
2017
Anticipated
Study Completion
Jan 31
2017
Anticipated
Last Update
Jul 26
2016
Estimate

Drug Ethanol 40% + Enoxaparine 400UI/ml

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

Experimental group Experimental

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 Other

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

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
No Results Posted