Clinical Trial: Prospective Population Study on Candidemia in Spain

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

Official Title: Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)

Brief Summary: The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.

Detailed Summary:
Sponsor: Fundacion SEIMC-GESIDA

Current Primary Outcome: Describe fungemia epidemiology in Spain [ Time Frame: 1 year ]

Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.


Original Primary Outcome: Describe fungemia epidemiology in Spain [ Time Frame: 1 year ]

Recolection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.


Current Secondary Outcome:

  • Describe differences among cities and institutions [ Time Frame: 1 year ]
    Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
  • Definition of risk factors [ Time Frame: 1 year ]

    Determine risk factors for:

    • bad clinical evolution
    • infection by a specific Candida species
    • fluconazole resistant isolate
    • fungemia persistency
  • Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B [ Time Frame: 1 year ]
    Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal
  • Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution [ Time Frame: 1 year ]
    Chi-square and Kaplan-Meier survival curves
  • Correlation between reference and commercial microbiological methods [ Time Frame: 1 year ]
    Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.


Original Secondary Outcome:

  • Describe differences among cities and institutions [ Time Frame: 1 year ]
    Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
  • Definition of risk factors [ Time Frame: 1 year ]

    Determine risk factors for:

    • bad clinical evolution
    • infection by a specific Candida species
    • floconazole resisant isolate
    • fungemia persistency
  • Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B [ Time Frame: 1 year ]
    Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal
  • Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution [ Time Frame: 1 year ]
    Chi-square and Kaplan-Meier survival curves
  • Correlation between reference and comercial microbiological methods [ Time Frame: 1 year ]
    Comparison of results when a reference or a comercial fungal identification and antifungal susceptibility method is used.


Information By: Fundacion SEIMC-GESIDA

Dates:
Date Received: November 5, 2010
Date Started: March 2013
Date Completion:
Last Updated: April 22, 2013
Last Verified: April 2013