Clinical trial NCT01236261: Prospective Population Study on Candidemia in Spain
Official title: Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungemia
Keywords: Fungemia, fungal infection, susceptibility, antifungal
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
name: Gilead Sciences
name: Merck Sharp & Dohme LLC
name: Pfizer
First posted: 2010-11-07
Enrollment: 730
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)

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.


Eligibility criteria: Inclusion Criteria:

* Fungal isolate obtained from blood sample

Exclusion Criteria:

* None

Primary outcomes:
measure: Describe fungemia epidemiology in Spain
timeFrame: 1 year
Secondary outcomes:
measure: Describe differences among cities and institutions
timeFrame: 1 year
measure: Definition of risk factors
timeFrame: 1 year
measure: Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B
timeFrame: 1 year
measure: Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution
timeFrame: 1 year
measure: Correlation between reference and commercial microbiological methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Dèu
state: Barcelona
city: Alcorcón
country: Spain
facility: Hospital Fundación de Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Bormujos
country: Spain
facility: Hospital San Juan de Dios del Aljarafe
state: Seville
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Basurto
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Galdakao
country: Spain
facility: Hospital de Galdakao-Usansolo
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital del Niño Jesús
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Seville
country: Spain
facility: Hospital Virgen de Macarena
city: Seville
country: Spain
facility: Clínica Sagrado Corazón
city: Seville
country: Spain
facility: Hospital Virgen del Rocío
city: Seville
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Valencia
country: Spain
facility: Hospital Doctor Peset
Study officials:
affiliation: Instituto de Salud Carlos III
name: Manuel Cuenca, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Gregorio Marañon
name: Belen Padilla, MD
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: Isabel Ruiz, MD
role: STUDY_DIRECTOR
affiliation: Hospital Virgen del Rocio
name: Jose Garnacho-Montero, MD
role: STUDY_DIRECTOR
References:
citation: 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.