Concentration of Antimicrobials in Catheter-lock Solutions

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.

Conditions

• Catheter-Related Infections
• Bacteremia.

Interventions

DRUG

Vancomycin antimicrobial-lock solution

Randomization of 5 patients into vancomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

DRUG

Teicoplanin antimicrobial-lock solution

Randomization of 5 patients into teicoplanin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

DRUG

Linezolid antimicrobial-lock solution

Randomization of 5 patients into linezolid antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

DRUG

Daptomycin antimicrobial-lock solution

Randomization of 5 patients into daptomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

DRUG

Tigecycline antimicrobial-lock solution

Randomization of 5 patients into tigecycline antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Sponsors & Collaborators

• University of Navarrra Hospital (Clinica Universitaria)

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• JOSE L DEL POZO, MD. Ph. D. · Clinica Universidad de Navarra

• CESAR E BUSTOS, MD. · Clinica Universidad de Navarra

• AITZIBER AGUINAGA, Pharm. D. · Clinica Universidad de Navarra

• JOSE R YUSTE, MD. Ph.D. · Clinica Universidad de Navarra

• JOSE R AZANZA, MD. Ph.D. · Clinica Universidad de Navarra

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2015-01-31

Completion

2015-12-31

Countries

• Spain

Study Locations