Prospective Population Study on Candidemia in Spain (CANDIPOP)

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma Inc
Gilead Sciences
Merck Sharp & Dohme Corp.
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
  Purpose

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 Intervention
Fungemia
Other: Non intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Fungal strains obtained from blood cultures.


Enrollment: 730
Study Start Date: March 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fungemia
Patients with a fungal isolate from a blood culture
Other: Non intervention
Non interventional study

  Eligibility

Genders Eligible for Study:   Both
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)

Criteria

Inclusion Criteria:

  • Fungal isolate obtained from blood sample

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236261

Locations
Spain
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 Clinic i Provincial
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Barcelona
Barcelona, Spain, 08034
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Vall d'Hebrón
Barcelona, Spain, 08035
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Infanta Leonor
Madrid, Spain, 28032
Hospital La Paz
Madrid, Spain, 28046
Hospital del Niño Jesús
Madrid, Spain, 28009
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Gregorio Marañon
Madrid, Spain, 28007
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital de la Princesa
Madrid, Spain, 28006
Clínica Sagrado Corazón
Seville, Spain, 41013
Hospital Virgen del Rocío
Seville, Spain, 41013
Hospital Nuestra Señora de Valme
Seville, Spain, 41014
Hospital Virgen de Macarena
Seville, Spain, 41009
Hospital Doctor Peset
Valencia, Spain, 46017
Hospital Clínico de Valencia
Valencia, Spain, 46010
Hospital General de Valencia
Valencia, Spain, 46014
Hospital La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Astellas Pharma Inc
Gilead Sciences
Merck Sharp & Dohme Corp.
Pfizer
Investigators
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
  More Information

No publications provided

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT01236261     History of Changes
Other Study ID Numbers: GEMICOMED-GEIH 0109
Study First Received: November 5, 2010
Last Updated: April 22, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Fungemia
Candidemia
Sepsis
Infection
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Candidiasis, Invasive
Candidiasis

ClinicalTrials.gov processed this record on August 21, 2014