drugset / Trial / NCT01592032

Concentration of Antimicrobials in Catheter-lock Solutions

NCT01592032

RandomizedParallel-groupOpen-labelTreatment

Summary

The antibiotic lock technique (ALT) is used as local treatment for Catheter-Related Bacteremia (CRB). It consists in the administration of a concentrated antimicrobial solution with a calculated volume to fill the lumen of the catheter. The lock solution is indwelled within the catheter for a defined period of hours or days before been removed. Currently, the Infectious Diseases Society of America (IDSA) Guidelines for treatment and management of CRB, recommends to change the antibiotic solution every 24 hours. The investigators expect to determine the stability of the concentration of vancomycin, teicoplanin, linezolid, daptomycin and tigecycline used in lock solutions, and thus to assay the optimal timeframe that the concentration of antibiotic used in lock solution keeps its in vivo antimicrobial activity. Study Hypothesis: An antibiotic lock solution maintains in vivo concentration and antimicrobial activity for at least 10 days after its infusion inside a subcutaneous port catheter.

Timeline

Start
2012-05
Primary completion
2015-01
Completion
2015-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Daptomycin Other / unclassified 5 mg/ml Other
Subject Linezolid Other / unclassified 1.8 mg/ml Other
Subject Teicoplanin Other / unclassified 10 mg/ml Other
Subject Tigecycline Small molecule 4.5 mg/ml Other
Subject Vancomycin Other / unclassified 2 mg/ml Other