Clinical Trial: Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST, and Pharmacokinetics/Pharmacodynamics)in Prognosis of Bacteremia by Enterobacteriaceae

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Study of the Impact of the Minimum Inhibitory Concentration and Susceptible Cut-off Points (CLSI, EUCAST and Pharmacokinetic/Pharmacodynamic) in Prognosis of Bacteremia by

Brief Summary: Provide scientific and validated data to help International Authorities to set susceptible to antibiotics cut-off points in bacteremia by Enterobacteriaceae

Detailed Summary:
Sponsor: Fundación Pública Andaluza Progreso y Salud

Current Primary Outcome:

  • Correlation between the MIC of different antibiotics and the prognosis in patients with bacteremia. [ Time Frame: 36 months ]
    Study the correlation between the minimum inhibitory concentration (MIC) of cefotaxime, ceftriaxone, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin and levofloxacin and the prognosis in patients with bacteremia by enterobacteria, with or without mechanisms of resistance
  • Correlation between CLSI and EUCAST cut-off points, FC/FD cut-off points with clinical prognosis and of the microbiological response in patients with bacteremia. [ Time Frame: 36 months ]
    Determine if the CLSI and EUCAST (European Committee on Antimicrobial Susceptibility Testing) sensitive clinical cut-off points, as well as the suggested by pharmacokinetic and pharmacodynamic studies (FC/FD) are properly independent predictors of clinical prognosis and of the microbiological response in patients with bacteremia
  • Correlation between piperacillin/tazobactam serum concentrations and clinical prognosis [ Time Frame: 36 months ]
    Evaluate if piperacillin/tazobactam serum concentrations are correlated with prognosis based on clinical sensitive cut-off points by CLSI and EUCAST


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Dates:
Date Received: November 14, 2013
Date Started: March 2011
Date Completion:
Last Updated: August 4, 2015
Last Verified: August 2015