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OpenTrials
Completed

NCT Number: NCT01236261

Prospective Population Study on Candidemia in Spain

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.

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Key information

Conditions

Fungemia Bacterial Infections and Mycoses Disease Attributes Disease Susceptibility Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinic i Provincial, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fungal isolate obtained from blood sample

Exclusion criteria

  • None

Treatment and study plan

Non intervention

Other

Non interventional study

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution

    Time frame: 1 year

    Chi-square and Kaplan-Meier survival curves

  5. 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.

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Astellas Pharma Inc
  • Gilead Sciences
  • Merck Sharp & Dohme LLC
  • Pfizer

Registry information

Official study title

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

Acronym: CANDIPOP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2010
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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