CClinicalTrials.gg
CompletedNCT01236261CANDIPOPUpdated Apr 23, 2013

Prospective Population Study on Candidemia in Spain

An observational study in Fungemia, sponsored by Fundacion SEIMC-GESIDA. Completed at 29 sites in Spain. Per ClinicalTrials.gov, last updated 2013-04-23.

Sponsored by Fundacion SEIMC-GESIDA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
730
Sex
All
01

Study 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.

02

Conditions studied

  • Fungemia

Browse trials for

Keywords

  • Fungemia, fungal infection, susceptibility, antifungal
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • None
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
730 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Fungemia

    Patients with a fungal isolate from a blood culture

    Other: Non intervention

Interventions

  • OtherNon intervention

    Non interventional study

05

What researchers measure

Primary outcomes

  1. Describe fungemia epidemiology in Spain

    Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.

    Time frame: 1 year

Secondary outcomes

  1. Describe differences among cities and institutions

    Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)

    Time frame: 1 year

  2. Definition of risk factors

    Determine risk factors for: * bad clinical evolution * infection by a specific Candida species * fluconazole resistant isolate * fungemia persistency

    Time frame: 1 year

  3. Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B

    Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal

    Time frame: 1 year

  4. Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution

    Chi-square and Kaplan-Meier survival curves

    Time frame: 1 year

  5. Correlation between reference and commercial microbiological methods

    Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.

    Time frame: 1 year

06

Study locations

29 sites
  • Hospital Sant Joan de Dèu
    Esplugues de Llobregat, Barcelona 08950, Spain
  • Hospital Fundación de Alcorcón
    Alcorcón, Madrid 28922, Spain
  • Hospital Puerta de Hierro Majadahonda
    Majadahonda, Madrid 28222, Spain
  • Hospital San Juan de Dios del Aljarafe
    Bormujos, Seville 41930, Spain
  • Hospital de Cruces
    Baracaldo, Vizcaya 48903, Spain
  • Hospital de Basurto
    Basurto, Vizcaya 48013, Spain
  • Hospital de Galdakao-Usansolo
    Galdakao, Vizcaya 48960, Spain
  • Hospital del Mar
    Barcelona, 08003, Spain
  • Hospital de Barcelona
    Barcelona, 08034, Spain
  • Hospital Vall d'Hebrón
    Barcelona, 08035, Spain
  • Hospital Clinic i Provincial
    Barcelona, 08036, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08041, Spain
  • Hospital de la Princesa
    Madrid, 28006, Spain
  • Hospital Gregorio Marañon
    Madrid, 28007, Spain
  • Hospital del Niño Jesús
    Madrid, 28009, Spain
  • Hospital Infanta Leonor
    Madrid, 28032, Spain
  • Hospital Ramon y Cajal
    Madrid, 28034, Spain
  • Fundación Jiménez Díaz
    Madrid, 28040, Spain
  • Hospital Clínico San Carlos
    Madrid, 28040, Spain
  • Hospital 12 de Octubre
    Madrid, 28041, Spain
  • Hospital La Paz
    Madrid, 28046, Spain
  • Hospital Virgen de Macarena
    Seville, 41009, Spain
  • Clínica Sagrado Corazón
    Seville, 41013, Spain
  • Hospital Virgen del Rocío
    Seville, 41013, Spain
  • Hospital Nuestra Señora de Valme
    Seville, 41014, Spain
  • Hospital La Fe
    Valencia, 46009, Spain
  • Hospital Clínico de Valencia
    Valencia, 46010, Spain
  • Hospital General de Valencia
    Valencia, 46014, Spain
  • Hospital Doctor Peset
    Valencia, 46017, Spain
07

References and documents

Publications

  • Puig-Asensio M, Fernandez-Ruiz M, Aguado JM, Merino P, Lora-Pablos D, Guinea J, Martin-Davila 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. PubMed 26976872 ↗
08

Registry details

Key details

Study ID
NCT01236261
Lead sponsor
Fundacion SEIMC-GESIDA
Collaborators
Astellas Pharma Inc, Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer
Responsible party
Sponsor
First posted
Nov 7, 2010
Start date
Mar 2013
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Apr 23, 2013

Study contacts

Manuel Cuenca, MD, PhD
study director · Instituto de Salud Carlos III
Belen Padilla, MD
study director · Hospital Gregorio Marañon
Isabel Ruiz, MD
study director · Hospital Vall d'Hebron
Jose Garnacho-Montero, MD
study director · Hospital Virgen del Rocio

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion