Prospective Population Study on Candidemia in Spain

NCT01236261

Last updated date
Study Location
Hospital Sant Joan de Dèu
Esplugues de Llobregat, Barcelona, 08950, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fungemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Fungal isolate obtained from blood sample

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- None

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FungemiaProspective Population Study on Candidemia in Spain
NCT01236261
  1. Esplugues de Llobregat, Barcelona
  2. Alcorcón, Madrid
  3. Majadahonda, Madrid
  4. Bormujos, Seville
  5. Baracaldo, Vizcaya
  6. Basurto, Vizcaya
  7. Galdakao, Vizcaya
  8. Barcelona,
  9. Barcelona,
  10. Barcelona,
  11. Barcelona,
  12. Barcelona,
  13. Madrid,
  14. Madrid,
  15. Madrid,
  16. Madrid,
  17. Madrid,
  18. Madrid,
  19. Madrid,
  20. Madrid,
  21. Madrid,
  22. Seville,
  23. Seville,
  24. Seville,
  25. Seville,
  26. Valencia,
  27. Valencia,
  28. Valencia,
  29. Valencia,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prospective Population Study on Candidemia in Spain
Official Title Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Fungal strains obtained from blood cultures.
Sampling Method Non-Probability Sample
Study Population All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)
Condition Fungemia
Intervention Other: Non intervention
Non interventional study
Study Groups/Cohorts Fungemia
Patients with a fungal isolate from a blood culture
Intervention: Other: Non intervention
Publications * Puig-Asensio M, Fernández-Ruiz M, Aguado JM, Merino P, Lora-Pablos D, Guinea J, Martín-Dávila P, Cuenca-Estrella M, Almirante B. Propensity Score Analysis of the Role of Initial Antifungal Therapy in the Outcome of Candida glabrata Bloodstream Infections. Antimicrob Agents Chemother. 2016 May 23;60(6):3291-300. doi: 10.1128/AAC.00195-16. Print 2016 Jun.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2013)
730
Original Estimated Enrollment
 (submitted: November 5, 2010)
500
Actual Study Completion Date March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Fungal isolate obtained from blood sample

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01236261
Other Study ID Numbers GEMICOMED-GEIH 0109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fundacion SEIMC-GESIDA
Study Sponsor Fundacion SEIMC-GESIDA
Collaborators
  • Astellas Pharma Inc
  • Gilead Sciences
  • Merck Sharp & Dohme Corp.
  • Pfizer
Investigators
Study Director:Manuel Cuenca, MD, PhDInstituto de Salud Carlos III
Study Director:Belen Padilla, MDHospital Gregorio Marañon
Study Director:Isabel Ruiz, MDHospital Vall d'Hebron
Study Director:Jose Garnacho-Montero, MDHospital Virgen del Rocio
PRS Account Fundacion SEIMC-GESIDA
Verification Date April 2013