Prospective Population Study on Candidemia in Spain

Completed

• Conditions: Fungemia
• Interventions: Other: Non intervention

• Registration Number: NCT01236261
• Lead Sponsor: Fundacion SEIMC-GESIDA

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 available

Study Timeline

• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Study Start: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

• Fungal isolate obtained from blood sample

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fungemia	Non intervention	Patients with a fungal isolate from a blood culture

Primary Outcome Measures

Name	Time	Method
Describe fungemia epidemiology in Spain	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution	1 year	Chi-square and Kaplan-Meier survival curves
Describe differences among cities and institutions	1 year	Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
Correlation between reference and commercial microbiological methods	1 year	Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.
Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B	1 year	Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal
Definition of risk factors	1 year	Determine risk factors for: * bad clinical evolution; * infection by a specific Candida species; * fluconazole resistant isolate; * fungemia persistency

Trial Locations

Locations (29)

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Hospital Virgen del Rocío; 🇪🇸 Seville, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital de Cruces; 🇪🇸 Baracaldo, Vizcaya, Spain

Hospital de Galdakao-Usansolo; 🇪🇸 Galdakao, Vizcaya, Spain

Hospital de la Princesa; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Fundación de Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Clinic i Provincial; 🇪🇸 Barcelona, Spain

Hospital San Juan de Dios del Aljarafe; 🇪🇸 Bormujos, Seville, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital del Niño Jesús; 🇪🇸 Madrid, Spain

Hospital Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospital de Basurto; 🇪🇸 Basurto, Vizcaya, Spain

Hospital Nuestra Señora de Valme; 🇪🇸 Seville, Spain

Hospital Sant Joan de Dèu; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain

Hospital General de Valencia; 🇪🇸 Valencia, Spain

Hospital Virgen de Macarena; 🇪🇸 Seville, Spain

Clínica Sagrado Corazón; 🇪🇸 Seville, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital de Barcelona; 🇪🇸 Barcelona, Spain