Prospective Population Study on Candidemia in Spain (CANDIPOP)

April 22, 2013 updated by: Fundacion SEIMC-GESIDA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

730

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08034
        • Hospital de Barcelona
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital Gregorio Marañón
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28009
        • Hospital del Nino Jesus
      • Madrid, Spain, 28032
        • Hospital Infanta Leonor
      • Seville, Spain, 41013
        • Hospital Virgen del Rocío
      • Seville, Spain, 41009
        • Hospital Virgen de Macarena
      • Seville, Spain, 41013
        • Clínica Sagrado Corazón
      • Seville, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Spain, 46014
        • Hospital General de Valencia
      • Valencia, Spain, 46009
        • Hospital La Fe
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Fundación de Alcorcón
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro Majadahonda
    • Seville
      • Bormujos, Seville, Spain, 41930
        • Hospital San Juan de Dios del Aljarafe
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces
      • Basurto, Vizcaya, Spain, 48013
        • Hospital de Basurto
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital de Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)

Description

Inclusion Criteria:

  • Fungal isolate obtained from blood sample

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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
1 year
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
1 year
Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution
Time Frame: 1 year
Chi-square and Kaplan-Meier survival curves
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion SEIMC-GESIDA

Collaborators

Merck Sharp & Dohme LLC
Pfizer
Gilead Sciences
Astellas Pharma Inc

Investigators

  • Study Director: Manuel Cuenca, MD, PhD, Instituto de Salud Carlos III
  • Study Director: Belen Padilla, MD, Hospital Gregorio Marañón
  • Study Director: Isabel Ruiz, MD, Hospital Vall d'Hebron
  • Study Director: Jose Garnacho-Montero, MD, Hospital Virgen del Rocío

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 7, 2010

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMICOMED-GEIH 0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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