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Prospective Population Study on Candidemia in Spain (CANDIPOP)

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma Inc
Gilead Sciences
Merck
Pfizer
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01236261
First received: November 5, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes

November 5, 2010
April 22, 2013
March 2013
March 2013   (final data collection date for primary outcome measure)
Describe fungemia epidemiology in Spain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.
Describe fungemia epidemiology in Spain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Recolection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.
Complete list of historical versions of study NCT01236261 on ClinicalTrials.gov Archive Site
  • Describe differences among cities and institutions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Chi-square and Kaplan-Meier survival curves
  • Correlation between reference and commercial microbiological methods [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.
  • Describe differences among cities and institutions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Chi-square and Kaplan-Meier survival curves
  • Correlation between reference and comercial microbiological methods [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison of results when a reference or a comercial fungal identification and antifungal susceptibility method is used.
Not Provided
Not Provided
 
Prospective Population Study on Candidemia in Spain
Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Fungal strains obtained from blood cultures.
Non-Probability Sample

All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)
Fungemia
Other: Non intervention
Non interventional study
Fungemia
Patients with a fungal isolate from a blood culture
Intervention: Other: Non intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
730
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fungal isolate obtained from blood sample

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01236261
GEMICOMED-GEIH 0109
Yes
Fundacion SEIMC-GESIDA
Fundacion SEIMC-GESIDA
  • Astellas Pharma Inc
  • Gilead Sciences
  • Merck
  • Pfizer
Study Director: Manuel Cuenca, MD, PhD Instituto de Salud Carlos III
Study Director: Belen Padilla, MD Hospital Gregorio Marañon
Study Director: Isabel Ruiz, MD Hospital Vall d'Hebron
Study Director: Jose Garnacho-Montero, MD Hospital Virgen del Rocio
Fundacion SEIMC-GESIDA
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP