Clinical Trial: The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Daptomycin in the Levels of IL-1, IL-6 and TNF in Patients With Complicated Cellulitis/Erisipela in Comparison With Vancomycin or Oxacillin

Brief Summary: Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both groups according to levels of the cytokines evaluated.

Detailed Summary:
Sponsor: Hospital Universitario Evangelico de Curitiba

Current Primary Outcome: Cytokine levels [ Time Frame: AUC will be calculated with multiple time points over a period of 14 days (0, 4, 8, 12 , 16, 24, 48, 72, 96, 120 and 168 hours post‐dose) ]

The results of cytokine levels will be evaluated after completion of antibiotic therapy, when testing will take place in the laboratory. Thus the measurement of cytokines will not be used to evaluate the clinical outcome.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital Universitario Evangelico de Curitiba

Dates:
Date Received: March 23, 2012
Date Started: July 2012
Date Completion:
Last Updated: March 19, 2015
Last Verified: March 2015