NCT01236261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
2.3 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

Same day

First QC Date

November 5, 2010

Last Update Submit

April 22, 2013

Conditions

Keywords

Fungemia, fungal infection, susceptibility, antifungal

Outcome Measures

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.

    1 year

Secondary Outcomes (5)

  • Describe differences among cities and institutions

    1 year

  • Definition of risk factors

    1 year

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

    1 year

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

    1 year

  • Correlation between reference and commercial microbiological methods

    1 year

Study Arms (1)

Fungemia

Patients with a fungal isolate from a blood culture

Other: Non intervention

Interventions

Non interventional study

Fungemia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Fungal isolate obtained from blood sample

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Barcelona

Barcelona, Barcelona, 08034, Spain

Location

Hospital Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Hospital Sant Joan de Dèu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Fundación de Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital de la Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Hospital del Niño Jesús

Madrid, Madrid, 28009, Spain

Location

Hospital Infanta Leonor

Madrid, Madrid, 28032, Spain

Location

Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital San Juan de Dios del Aljarafe

Bormujos, Seville, 41930, Spain

Location

Hospital Virgen de Macarena

Seville, Seville, 41009, Spain

Location

Clínica Sagrado Corazón

Seville, Seville, 41013, Spain

Location

Hospital Virgen del Rocío

Seville, Seville, 41013, Spain

Location

Hospital Nuestra Señora de Valme

Seville, Seville, 41014, Spain

Location

Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital de Basurto

Basurto, Vizcaya, 48013, Spain

Location

Hospital de Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fungal strains obtained from blood cultures.

MeSH Terms

Conditions

FungemiaMycosesDisease Susceptibility

Condition Hierarchy (Ancestors)

Invasive Fungal InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 8, 2010

Study Start

March 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations