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Prospective Population Study on Candidemia in Spain

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01236261
Acronym
CANDIPOP
Enrollment
730
Registered
2010-11-08
Start date
2013-03-31
Completion date
2013-03-31
Last updated
2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungemia

Keywords

Fungemia, fungal infection, susceptibility, antifungal

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.

Interventions

OTHERNon intervention

Non interventional study

Sponsors

Astellas Pharma Inc
CollaboratorINDUSTRY
Gilead Sciences
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Pfizer
CollaboratorINDUSTRY
Fundacion SEIMC-GESIDA
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Fungal isolate obtained from blood sample

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Describe fungemia epidemiology in Spain1 yearRecollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.

Secondary

MeasureTime frameDescription
Describe differences among cities and institutions1 yearAnalyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
Definition of risk factors1 yearDetermine 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 B1 yearAnalysis 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 evolution1 yearChi-square and Kaplan-Meier survival curves
Correlation between reference and commercial microbiological methods1 yearComparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026