Prospective Population Study on Candidemia in Spain (CANDIPOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236261
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : April 23, 2013
Astellas Pharma Inc
Gilead Sciences
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Fungemia Other: Non intervention

Study Type : Observational
Actual Enrollment : 730 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)
Study Start Date : March 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with a fungal isolate from a blood culture
Other: Non intervention
Non interventional study

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA
Fungal strains obtained from blood cultures.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)

Inclusion Criteria:

  • Fungal isolate obtained from blood sample

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01236261

Hospital Sant Joan de Dèu
Esplugues de Llobregat, Barcelona, Spain, 08950
Hospital Fundación de Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital San Juan de Dios del Aljarafe
Bormujos, Seville, Spain, 41930
Hospital de Cruces
Baracaldo, Vizcaya, Spain, 48903
Hospital de Basurto
Basurto, Vizcaya, Spain, 48013
Hospital de Galdakao-Usansolo
Galdakao, Vizcaya, Spain, 48960
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Barcelona
Barcelona, Spain, 08034
Hospital Vall d'Hebrón
Barcelona, Spain, 08035
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital de la Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañon
Madrid, Spain, 28007
Hospital del Niño Jesús
Madrid, Spain, 28009
Hospital Infanta Leonor
Madrid, Spain, 28032
Hospital Ramon y Cajal
Madrid, Spain, 28034
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen de Macarena
Seville, Spain, 41009
Clínica Sagrado Corazón
Seville, Spain, 41013
Hospital Virgen del Rocío
Seville, Spain, 41013
Hospital Nuestra Señora de Valme
Seville, Spain, 41014
Hospital La Fe
Valencia, Spain, 46009
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital General de Valencia
Valencia, Spain, 46014
Hospital Doctor Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Astellas Pharma Inc
Gilead Sciences
Merck Sharp & Dohme Corp.
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fundacion SEIMC-GESIDA Identifier: NCT01236261     History of Changes
Other Study ID Numbers: GEMICOMED-GEIH 0109
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Fundacion SEIMC-GESIDA:
Fungemia, fungal infection, susceptibility, antifungal

Additional relevant MeSH terms:
Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes