Catheter-Related Infections Clinical Trial
Official title:
Concentration and Antibiotic Activity in Antibiotic Lock Solutions
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.
Primary Objective: Assess the antimicrobial concentration of catheter-lock solutions at the
end of port indwelling time. Secondary Objectives: 1) Assess bioactivity of antimicrobials
in lock solutions at the end of port indwelling time. 2) Assess anticoagulant activity of
antimicrobial-lock solutions at the end of port indwelling time.
Methods: Randomized, open, block allocation according to time of indwelling of the
antimicrobial-lock within the ports, unicentric, clinical trial in patients older than 18
years old with a venous port implanted at Clínica Universidad de Navarra. Intevention:
Randomization of 5 patients into one of five antimicrobial-lock solution arms for 1, 3, 5, 7
and 10 days according to HPLC corrected by urea gradient. Any study arm can be stopped at
any time from day 1 to day 10, in case of antimicrobial concentration would be less than 1
mg/mL.
At the end of each antimicrobial lock time frame of ports (1, 3, 5, 7 and 10 days), the
antimicrobial concentration will be determined by high performance liquid chromatography
(HPLC) and corrected by urea gradient. The cut-off for the median antimicrobial
concentration is 1 mg/mL.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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