drugset / 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
Unknown
180 enrolled
University Hospital, Clermont-Ferrand
CH Henri Mondor (Aurillac) · collabCH de Chambéry · collabCentre Jean Perrin · collabCentre Leon Berard · collabHôpital Nord (Saint-Etienne) · collabHôpital de la Croix-Rousse · collabJacques Lacarin Hospital Center · collabUniversity Hospital, Grenoble · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2015-03
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | 40 % | Other |
| Subject | Vancomycin | Other / unclassified | 5 mg/ml | Other |
| Background | Enoxaparin sodium | Other / unclassified | — | Other |
| Background | Heparin | Other / unclassified | — | Other |